Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00281580
First received: January 24, 2006
Last updated: July 17, 2012
Last verified: July 2012
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Results First Received: November 18, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Factorial Assignment; Masking: Double-Blind; Primary Purpose: Treatment |
| Condition: |
Hypertension |
| Interventions: |
Drug: Amlodipine 5 mg Drug: Placebo Drug: Telmisartan 20 mg Drug: Telmisartan 40 mg Drug: Amlodipine 10 mg Drug: Telmisartan 80 mg Drug: Amlodipine 2.5 mg |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Participant Flow: Overall Study
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| STARTED | 46 | 42 | 130 | 135 | 44 | 46 | 44 | 47 | 143 | 129 | 48 | 146 | 142 | 50 | 140 | 129 |
| COMPLETED | 39 | 41 | 125 | 118 | 40 | 43 | 39 | 46 | 135 | 117 | 44 | 136 | 129 | 43 | 133 | 116 |
| NOT COMPLETED | 7 | 1 | 5 | 17 | 4 | 3 | 5 | 1 | 8 | 12 | 4 | 10 | 13 | 7 | 7 | 13 |
| Adverse Event | 2 | 0 | 2 | 4 | 1 | 0 | 1 | 0 | 1 | 6 | 0 | 5 | 8 | 2 | 3 | 3 |
| Protocol Violation | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 2 | 0 | 1 | 1 | 3 |
| Withdrawal by Subject | 3 | 0 | 1 | 1 | 1 | 2 | 2 | 0 | 1 | 4 | 1 | 1 | 2 | 2 | 1 | 5 |
| Lack of Efficacy | 2 | 1 | 1 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 0 |
| Lost to Follow-up | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Randomised in error; prenancy; moving | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 2 | 1 | 1 | 1 | 2 | 0 | 1 | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
| Total | Total of all reporting groups |
Baseline Measures
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
46 | 42 | 130 | 135 | 44 | 46 | 44 | 47 | 143 | 129 | 48 | 146 | 142 | 50 | 140 | 129 | 1461 |
|
Age
[units: Years] Mean ± Standard Deviation |
52.5 ± 12.3 | 53.6 ± 10.4 | 52 ± 11 | 53.1 ± 11.3 | 54 ± 10.8 | 54.4 ± 10.2 | 51 ± 11.2 | 50.7 ± 10.2 | 52.3 ± 11.9 | 53.3 ± 11.3 | 54.8 ± 9.7 | 52.7 ± 11.9 | 53.9 ± 11.6 | 55.3 ± 10.4 | 53.1 ± 10.6 | 53.4 ± 10.7 | 53.1 ± 11.1 |
|
Gender
[units: Participants] |
|||||||||||||||||
| Female | 17 | 16 | 64 | 75 | 18 | 25 | 18 | 21 | 72 | 67 | 26 | 72 | 78 | 23 | 68 | 64 | 724 |
| Male | 29 | 26 | 66 | 60 | 26 | 21 | 26 | 26 | 71 | 62 | 22 | 74 | 64 | 27 | 72 | 65 | 737 |
Outcome Measures
| 1. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) |
| Measure Description | Observed results |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Full Analysis Set (FAS) |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups |
| Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 |
| Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 |
| Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
Measured Values
| Telmisartan 0 mg (T0) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
355 | 171 | 440 | 457 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP)
[units: mmHg] Mean ± Standard Deviation |
-13 ± 8.8 | -16.4 ± 7.8 | -16.2 ± 8.9 | -16.9 ± 8.6 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP)
| 2. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP |
| Measure Description | Telmisartan treatment effect on outcome measure |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups |
| Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 |
| Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 |
| Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
Measured Values
| Telmisartan 0 mg (T0) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
355 | 171 | 440 | 457 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP
[units: mmHg] Least Squares Mean ± Standard Error |
-12.5 ± 0.5 | -16.7 ± 0.6 | -16.6 ± 0.4 | -17.2 ± 0.4 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP
| 3. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP |
| Measure Description | Observed results |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
Measured Values
| Placebo (Pl) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
349 | 185 | 466 | 423 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Deviation |
-12.3 ± 9.7 | -14.9 ± 8.8 | -15.6 ± 8.1 | -18.6 ± 7.7 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP
| 4. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) |
| Measure Description | Amlodipine treatment effect on outcome measure |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
Measured Values
| Placebo (Pl) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
349 | 185 | 466 | 423 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
[units: mmHg] Least Squares Mean ± Standard Error |
-12.2 ± 0.5 | -15.3 ± 0.6 | -16.2 ± 0.4 | -19.3 ± 0.4 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
| 5. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) |
| Measure Description | Observed results |
| Time Frame | End-of-study visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 42 | 129 | 132 | 44 | 45 | 40 | 47 | 141 | 123 | 46 | 143 | 136 | 48 | 137 | 124 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
[units: mmHg] Mean ± Standard Deviation |
-5.9 ± 9.4 | -13.2 ± 9 | -13.1 ± 10.1 | -13.6 ± 8.7 | -18 ± 7.8 | -15.7 ± 6.5 | -18.7 ± 7 | -16.2 ± 8.2 | -16 ± 7.6 | -19.6 ± 7.9 | -15.3 ± 7.5 | -17.8 ± 8.5 | -19.6 ± 7.9 | -10.4 ± 9.9 | -13 ± 7.9 | -16.5 ± 7.1 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
| 6. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) |
| Measure Description | Individual treatment group effects (all patients) |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 42 | 129 | 132 | 44 | 45 | 40 | 47 | 141 | 123 | 46 | 143 | 136 | 48 | 137 | 124 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)
[units: mmHg] Least Squares Mean ± Standard Error |
-6.2 ± 1.2 | -13.8 ± 1.3 | -13.4 ± 0.7 | -14 ± 0.7 | -18.3 ± 1.2 | -15.9 ± 1.2 | -19.3 ± 1.3 | -16.9 ± 1.2 | -16.5 ± 0.7 | -20.2 ± 0.7 | -15.7 ± 1.2 | -18.2 ± 0.7 | -20.1 ± 0.7 | -10.6 ± 1.2 | -13.4 ± 0.7 | -17.11 ± 0.7 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)
| 7. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) |
| Measure Description | Individual treatment group effects (excluding placebo patients) |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
42 | 129 | 132 | 44 | 45 | 40 | 47 | 141 | 123 | 46 | 143 | 136 | 48 | 137 | 124 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
[units: mmHg] Least Squares Mean ± Standard Error |
-13.8 ± 1.2 | -13.4 ± 0.7 | -14 ± 0.7 | -18.3 ± 1.2 | -15.9 ± 1.2 | -19.3 ± 1.3 | -16.9 ± 1.2 | -16.5 ± 0.7 | -20.2 ± 0.7 | -15.7 ± 1.2 | -18.2 ± 0.7 | -20.1 ± 0.7 | -10.6 ± 1.2 | -13.4 ± 0.7 | -17.1 ± 0.7 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
| 8. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | Observed results for moderate-severe (mod-sev) patients |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Moderate-severe hypertensive patients |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups |
| Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 |
| Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 |
| Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
Measured Values
| Telmisartan 0 mg (T0) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
256 | 129 | 334 | 331 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Deviation |
-13.1 ± 9 | -16.8 ± 8 | -16.9 ± 8.9 | -17.7 ± 8.8 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 9. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | Telm Effect - mod-sev patients |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
Measured Values
| Placebo (Pl) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
256 | 129 | 334 | 331 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Least Squares Mean ± Standard Error |
-12.7 ± 0.5 | -17.3 ± 0.7 | -17.3 ± 0.5 | -18 ± 0.5 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 10. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | Observed results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Amlodipine 0 mg (A0) - Overall | Overall: including Pl, T20, T40, and T80 treatment groups |
| Amlodipine 2.5 mg (A2.5) - Overall | Overall: including all treatment groups involving A2.5 |
| Amlodipine 5 mg (A5) - Overall | Overall: including all treatment groups involving A5 |
| Amlodipine 10 mg (A10) - Overall | Overall: including all treatment groups involving A10 |
Measured Values
| Amlodipine 0 mg (A0) - Overall | Amlodipine 2.5 mg (A2.5) - Overall | Amlodipine 5 mg (A5) - Overall | Amlodipine 10 mg (A10) - Overall | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
257 | 137 | 349 | 307 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Error |
-12.7 ± 10.1 | -16 ± 8.4 | -16.3 ± 8.3 | -19.2 ± 7.8 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 11. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | Amlodipine Effect (Amlo Effect) - mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Amlodipine 0 mg (A0) - Overall | Overall: including Pl, T20, T40, and T80 treatment groups |
| Amlodipine 2.5 mg (A2.5) - Overall | Overall: including all treatment groups involving A2.5 |
| Amlodipine 5 mg (A5) - Overall | Overall: including all treatment groups involving A5 |
| Amlodipine 10 mg (A10) - Overall | Overall: including all treatment groups involving A10 |
Measured Values
| Amlodipine 0 mg (A0) - Overall | Amlodipine 2.5 mg (A2.5) - Overall | Amlodipine 5 mg (A5) - Overall | Amlodipine 10 mg (A10) - Overall | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
257 | 137 | 349 | 307 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Error |
-12.5 ± 0.5 | -16.4 ± 0.7 | -16.7 ± 0.5 | -19.7 ± 0.5 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 12. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | Observed results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
35 | 33 | 100 | 89 | 34 | 34 | 28 | 30 | 108 | 96 | 36 | 106 | 100 | 37 | 101 | 83 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Error |
-5.5 ± 10.1 | -13.9 ± 9.4 | -13.8 ± 10.2 | -13.9 ± 9.2 | -18.4 ± 7.9 | -15.8 ± 6.4 | -19.5 ± 7.2 | -18.7 ± 7.9 | -16.8 ± 7.5 | -19.6 ± 8.3 | -16.3 ± 7.7 | -18.8 ± 9 | -20.4 ± 7.3 | -11.4 ± 8.3 | -13.1 ± 8.1 | -17.1 ± 7.6 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 13. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | ANCOVA results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
35 | 33 | 100 | 89 | 34 | 34 | 28 | 30 | 108 | 96 | 36 | 106 | 100 | 37 | 101 | 83 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Least Squares Mean ± Standard Error |
-5.8 ± 1.4 | -14.4 ± 1.4 | -14.2 ± 0.8 | -14.1 ± 0.9 | -18.9 ± 1.4 | -15.9 ± 1.4 | -19.7 ± 1.6 | -18.8 ± 1.5 | -17.2 ± 0.8 | -20.1 ± 0.8 | -16.6 ± 1.4 | -19.1 ± 0.8 | -21 ± 0.8 | -11.7 ± 1.4 | -13.3 ± 0.8 | -17.6 ± 0.9 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 14. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean DBP |
| Measure Description | ANCOVA results for mod-sev patients (excluding placebo) |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
33 | 100 | 89 | 34 | 34 | 28 | 30 | 108 | 96 | 36 | 106 | 100 | 37 | 101 | 83 |
|
Change From Baseline in Seated Trough Cuff Mean DBP
[units: mmHg] Least Squares Mean ± Standard Error |
-14.5 ± 1.4 | -14.2 ± 0.8 | -14.1 ± 0.9 | -18.9 ± 1.4 | -15.9 ± 1.4 | -19.7 ± 1.5 | -18.8 ± 1.5 | -17.2 ± 0.8 | -20.1 ± 0.8 | -16.6 ± 1.4 | -19.1 ± 0.8 | -21 ± 0.8 | -11.7 ± 1.3 | -13.3 ± 0.8 | -17.6 ± 0.9 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean DBP
| 15. Secondary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) |
| Measure Description | Individual treatment group effects (all patients) |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 42 | 129 | 132 | 44 | 45 | 40 | 47 | 141 | 123 | 46 | 143 | 136 | 48 | 137 | 124 |
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)
[units: mmHg] Least Squares Mean ± Standard Error |
-2.5 ± 1.8 | -15.1 ± 1.9 | -14.6 ± 1.1 | -14.3 ± 1.1 | -18.8 ± 1.9 | -21 ± 1.9 | -24.4 ± 2 | -21.9 ± 1.8 | -21.8 ± 1.1 | -24.7 ± 1.1 | -17.4 ± 1.8 | -22.1 ± 1 | -26.4 ± 1.1 | -11.4 ± 1.8 | -15.4 ± 1.1 | -20.7 ± 1.1 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Seated Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)
| 16. Secondary: | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups) |
| Measure Description | Individual treatment group effects (all patients) |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 42 | 128 | 129 | 44 | 45 | 40 | 47 | 139 | 123 | 46 | 142 | 134 | 46 | 137 | 122 |
|
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)
[units: mmHg] Least Squares Mean ± Standard Error |
-4.9 ± 1.2 | -10.4 ± 1.3 | -10 ± 0.8 | -11.1 ± 0.8 | -14.9 ± 1.3 | -13.1 ± 1.3 | -16.9 ± 1.3 | -15.8 ± 1.2 | -13.6 ± 0.7 | -18.4 ± 0.8 | -13.4 ± 1.2 | -16.2 ± 0.7 | -19 ± 0.7 | -8.1 ± 1.2 | -11.3 ± 0.7 | -14.6 ± 0.8 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP (Adjusted Treatment Effects, All Treatment Groups)
| 17. Secondary: | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups) |
| Measure Description | Individual treatment group effects (all patients) |
| Time Frame | Baseline to end-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
46 | 42 | 128 | 129 | 44 | 45 | 40 | 47 | 139 | 123 | 46 | 142 | 134 | 46 | 137 | 122 |
|
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)
[units: mmHg] Least Squares Mean ± Standard Error |
-0.5 ± 1.9 | -13.2 ± 2 | -13.2 ± 1.1 | -12.9 ± 1.1 | -17.4 ± 1.9 | -18.9 ± 1.9 | -22.3 ± 2 | -20.3 ± 1.8 | -20 ± 1.1 | -22.8 ± 1.1 | -17.4 ± 1.9 | -21.2 ± 1.1 | -24.9 ± 1.1 | -9.1 ± 1.9 | -14.7 ± 1.1 | -19.1 ± 1.2 |
No statistical analysis provided for Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP (Adjusted Treatment Effects, All Treatment Groups)
| 18. Secondary: | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects) [ Time Frame: Baseline to nominal week over the trial ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects) |
| Measure Description | Observed results for all patients - key combination therapies |
| Time Frame | Baseline to nominal week over the trial |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
141 | 123 | 142 | 136 |
|
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects)
[units: mmHg] Mean ± Standard Deviation |
||||
| Week 2 | -17.5 ± 12 | -18.3 ± 12.3 | -19.3 ± 12.9 | -17.5 ± 12.6 |
| Week 4 | -20.3 ± 11 | -22.7 ± 14.6 | -20.9 ± 12.3 | -23.9 ± 13.4 |
| Week 6 | -20.4 ± 12.3 | -23.3 ± 14.4 | -22.6 ± 14.7 | -24.3 ± 14.6 |
| Week 8 | -21.6 ± 11.7 | -23.5 ± 13.3 | -22.4 ± 12.7 | -26.3 ± 14.5 |
No statistical analysis provided for Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP (Observed Treatment Effects)
| 19. Secondary: | DBP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | DBP Control |
| Measure Description | Percentage of responders (DBP<90 mmHg) for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
141 | 123 | 143 | 136 |
|
DBP Control
[units: percentage of participants] |
71.6 | 82.1 | 74.8 | 85.3 |
No statistical analysis provided for DBP Control
| 20. Secondary: | DBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | DBP Response |
| Measure Description | Percentage of responders (DBP<90 mmHg or >=10 mmHg reduction) for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
141 | 123 | 143 | 136 |
|
DBP Response
[units: percentage of participants] |
80.9 | 91.9 | 88.8 | 91.2 |
No statistical analysis provided for DBP Response
| 21. Secondary: | SBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | SBP Response |
| Measure Description | Percentage of responders (SBP<140 mmHg or >=10 mmHg reduction) for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
139 | 123 | 142 | 134 |
|
SBP Response
[units: percentage of participants] |
91.5 | 96.7 | 87.4 | 94.9 |
No statistical analysis provided for SBP Response
| 22. Secondary: | BP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | BP Control |
| Measure Description | Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
141 | 123 | 143 | 136 |
|
BP Control
[units: percentage of participants] |
58.9 | 75.6 | 65.7 | 76.5 |
No statistical analysis provided for BP Control
| 23. Secondary: | BP Normality [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | BP Normality |
| Measure Description | Category based on both SBP and DBP (mmHg) for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
139 | 123 | 142 | 134 |
|
BP Normality
[units: percentage of participants] |
||||
| No (SBP>=140 and/or DBP>=90) | 41.1 | 24.4 | 34.3 | 23.5 |
| High Normal (140>SBP>=130 and 90>DBP>=85) | 28.4 | 30.1 | 30.1 | 22.1 |
| Normal (130>SBP>=120 and 85>DBP>=80) | 21.3 | 32.5 | 25.9 | 39.7 |
| Optimal (SBP<120 and DBP<80) | 9.2 | 13 | 9.8 | 14.7 |
No statistical analysis provided for BP Normality
| 24. Secondary: | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP (Observed Treatment Effects) [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP (Observed Treatment Effects) |
| Measure Description | Observed results for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
139 | 123 | 142 | 134 |
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP (Observed Treatment Effects)
[units: mmHg] Mean ± Standard Deviation |
||||
| Hour 1 | -10.7 ± 9.5 | -15.4 ± 11.6 | -12.7 ± 9.9 | -13.4 ± 9.7 |
| Hour 2 | -9.8 ± 11.7 | -15 ± 12.2 | -13.4 ± 9.5 | -14.6 ± 12.4 |
| Hour 3 | -11.2 ± 13.2 | -14.1 ± 12.6 | -14.8 ± 11.6 | -15.4 ± 12 |
| Hour 4 | -11.3 ± 11.8 | -16.5 ± 13.2 | -15.6 ± 11.7 | -15.8 ± 10.8 |
| Hour 5 | -13.1 ± 11 | -14.1 ± 14.4 | -16.3 ± 14.3 | -15.7 ± 10.9 |
| Hour 6 | -10.9 ± 11.6 | -14.5 ± 12.4 | -14.6 ± 9.9 | -16.4 ± 11 |
| Hour 7 | -12.8 ± 10.2 | -15.6 ± 13.9 | -12.9 ± 10.4 | -15.7 ± 14 |
| Hour 8 | -12.1 ± 12.3 | -17.4 ± 13.6 | -12.7 ± 13.6 | -17.1 ± 12.9 |
| Hour 9 | -13.1 ± 10.3 | -15.7 ± 14.4 | -14.3 ± 14.3 | -17.2 ± 13.8 |
| Hour 10 | -11.8 ± 10.3 | -13.8 ± 13.5 | -14.7 ± 15.7 | -18.5 ± 12.9 |
| Hour 11 | -11.2 ± 12.9 | -14.4 ± 11.9 | -15.1 ± 13.1 | -16.1 ± 12.8 |
| Hour 12 | -12 ± 11.3 | -13.3 ± 12.9 | -12.5 ± 14.8 | -15.7 ± 12.2 |
| Hour 13 | -10.3 ± 11.7 | -14.7 ± 14.3 | -14.1 ± 13.5 | -15.1 ± 10.6 |
| Hour 14 | -8.9 ± 13.2 | -14.8 ± 14.1 | -13.4 ± 13.4 | -11 ± 14.9 |
| Hour 15 | -10.3 ± 16 | -11.5 ± 14.3 | -11.9 ± 14.8 | -10 ± 12.7 |
| Hour 16 | -10.1 ± 15 | -10.3 ± 15.4 | -11.3 ± 12 | -12.2 ± 13.6 |
| Hour 17 | -9.8 ± 13.7 | -10.4 ± 14.4 | -11.2 ± 12.5 | -11.5 ± 13.1 |
| Hour 18 | -11.9 ± 15 | -9.9 ± 12.4 | -10.3 ± 12.3 | -12.2 ± 11.9 |
| Hour 19 | -9.1 ± 10.9 | -10.5 ± 13.7 | -11.9 ± 10.4 | -13.2 ± 11.3 |
| Hour 20 | -11 ± 11.9 | -9.9 ± 12.4 | -12.6 ± 11.1 | -15.9 ± 11.1 |
| Hour 21 | -10.4 ± 13 | -8.9 ± 13.2 | -8.5 ± 12.7 | -14.8 ± 9.7 |
| Hour 22 | -11.1 ± 12.6 | -9.8 ± 13.7 | -9.7 ± 12.9 | -15.4 ± 9.9 |
| Hour 23 | -9.8 ± 11.3 | -13.3 ± 13.4 | -9.9 ± 12.2 | -14.6 ± 9.4 |
| Hour 24 | -11.1 ± 9.5 | -12.6 ± 11.5 | -12 ± 13.1 | -13.1 ± 11.9 |
No statistical analysis provided for Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP (Observed Treatment Effects)
| 25. Secondary: | Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects) |
| Measure Description | Observed results for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
57 | 57 | 56 | 52 |
|
Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects)
[units: mmHg] Mean ± Standard Deviation |
-11 ± 7.2 | -13.2 ± 7.7 | -12.8 ± 7.4 | -14.6 ± 6.9 |
No statistical analysis provided for Change From Baseline in ABPM 24-hour Mean DBP (Observed Treatment Effects)
| 26. Secondary: | Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects) [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects) |
| Measure Description | Observed results for all patients - key combination therapies |
| Time Frame | End-of-study (up to 8 weeks) visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
57 | 57 | 56 | 52 |
|
Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects)
[units: mmHg] Mean ± Standard Deviation |
-17.3 ± 10.4 | -20.5 ± 13.9 | -19.5 ± 11.6 | -22.4 ± 9.8 |
No statistical analysis provided for Change From Baseline in ABPM 24-hour Mean SBP (Observed Treatment Effects)
| 27. Secondary: | Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Orthostatic Change in Trough Cuff Mean DBP |
| Measure Description | Calculated as seated minus standing for all patients - key combination therapies |
| Time Frame | Week 8 |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
133 | 112 | 132 | 121 |
|
Orthostatic Change in Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Deviation |
2.2 ± 5.7 | 1.7 ± 5.4 | 2 ± 5.4 | 1.1 ± 4.9 |
No statistical analysis provided for Orthostatic Change in Trough Cuff Mean DBP
| 28. Secondary: | Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Orthostatic Change in Trough Cuff Mean SBP |
| Measure Description | Calculated as seated minus standing for all patients - key combination therapies |
| Time Frame | Week 8 |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
133 | 112 | 132 | 121 |
|
Orthostatic Change in Trough Cuff Mean SBP
[units: mmHg] Mean ± Standard Deviation |
0 ± 7.5 | 0.6 ± 8 | 0.9 ± 7.5 | 0.8 ± 7.3 |
No statistical analysis provided for Orthostatic Change in Trough Cuff Mean SBP
| 29. Secondary: | Change From Baseline in Seated Trough Pulse Rate [ Time Frame: End-of-study visit (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Pulse Rate |
| Measure Description | Observed results for all patients - key combination therapies |
| Time Frame | End-of-study visit (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
141 | 123 | 143 | 136 |
|
Change From Baseline in Seated Trough Pulse Rate
[units: bpm] Mean ± Standard Deviation |
0 ± 8.8 | 0 ± 9.5 | 2.4 ± 9.3 | -1.5 ± 9.7 |
No statistical analysis provided for Change From Baseline in Seated Trough Pulse Rate
| 30. Secondary: | Change From Baseline in Seated Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff Mean SBP |
| Measure Description | ANCOVA results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
35 | 33 | 100 | 89 | 34 | 34 | 28 | 30 | 108 | 96 | 36 | 106 | 100 | 37 | 101 | 83 |
|
Change From Baseline in Seated Trough Cuff Mean SBP
[units: mmHg] Least Squares Mean ± Standard Error |
-1.9 ± 2.1 | -15.6 ± 2.1 | -15.4 ± 1.2 | -15.4 ± 1.3 | -19 ± 2.1 | -22.1 ± 2.1 | -25.2 ± 2.3 | -23.2 ± 2.2 | -22.2 ± 1.2 | -25.3 ± 1.3 | -17.4 ± 2 | -22.5 ± 1.2 | -26.5 ± 1.2 | -12.4 ± 2 | -14.8 ± 1.2 | -21 ± 1.4 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff Mean SBP
| 31. Secondary: | Change From Baseline in Standing Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Standing Trough Cuff Mean DBP |
| Measure Description | ANCOVA results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 20 mg (T20) | monotherapy |
| Telmisartan 40 mg (T40) | monotherapy |
| Telmisartan 80 mg (T80) | monotherapy |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | combination therapy |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | combination therapy |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | combination therapy (T20+A5 titrated to T20+A10) |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | combination therapy |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | combination therapy |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | combination therapy (T40+A5 titrated to T40+A10) |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | combination therapy |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | combination therapy |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | combination therapy (T80+A5 titrated to T80+A10) |
| Amlodipine 2.5 mg (A2.5) | monotherapy |
| Amlodipine 5 mg (A5) | monotherapy |
| Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
| Placebo (Pl) | No text entered. |
Measured Values
| Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | Placebo (Pl) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
33 | 99 | 86 | 34 | 34 | 28 | 30 | 107 | 96 | 36 | 105 | 100 | 35 | 101 | 81 | 35 |
|
Change From Baseline in Standing Trough Cuff Mean DBP
[units: mmHg] Least Squares Mean ± Standard Error |
-11.7 ± 1.5 | -10.9 ± 0.9 | -11.3 ± 0.9 | -15.1 ± 1.4 | -13.3 ± 1.4 | -17.6 ± 1.6 | -17.5 ± 1.5 | -14.2 ± 0.8 | -18 ± 0.9 | -14.5 ± 1.4 | -17.3 ± 0.8 | -19.2 ± 0.8 | -8 ± 1.4 | -11 ± 0.8 | -15.5 ± 0.9 | -4.2 ± 1.4 |
No statistical analysis provided for Change From Baseline in Standing Trough Cuff Mean DBP
| 32. Secondary: | Change From Baseline in Standing Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Standing Trough Cuff Mean SBP |
| Measure Description | ANCOVA results for mod-sev patients |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning |
| Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning |
| Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning |
| Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | T20mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | T20mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | T20mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | T40mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | T80mg tab plus encapsulated A2.5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning |
| Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning |
| Amlodipine 10 mg (A10) | 2 encapsulated Amlodipine 5 mg capsule, QD in morning |
Measured Values
| Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
35 | 33 | 99 | 86 | 34 | 34 | 28 | 30 | 107 | 96 | 36 | 105 | 100 | 35 | 101 | 81 |
|
Change From Baseline in Standing Trough Cuff Mean SBP
[units: mmHg] Least Squares Mean ± Standard Error |
1 ± 2.1 | -13.7 ± 2.1 | -13.6 ± 1.2 | -14 ± 1.3 | -16.2 ± 2.1 | -19.4 ± 2.1 | -23.2 ± 2.3 | -21.8 ± 2.2 | -20.4 ± 1.2 | -22.8 ± 1.3 | -16.3 ± 2 | -21.9 ± 1.2 | -24.3 ± 1.2 | -10.1 ± 2.1 | -13.2 ± 1.2 | -19.3 ± 1.4 |
No statistical analysis provided for Change From Baseline in Standing Trough Cuff Mean SBP
| 33. Secondary: | Change From Baseline in Seated Trough Cuff DBP [ Time Frame: Nominal week over the trial ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Cuff DBP |
| Measure Description | Observed results for mod-sev patients - key combination therapies |
| Time Frame | Nominal week over the trial |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
Change From Baseline in Seated Trough Cuff DBP
[units: mmHg] Mean ± Standard Deviation |
||||
| Week 2 | -14.7 ± 8.9 | -14.7 ± 7.8 | -16.1 ± 7.9 | -14.9 ± 6.7 |
| Week 4 | -16.5 ± 6.8 | -18.2 ± 9.2 | -17.8 ± 7.6 | -19.2 ± 6.8 |
| Week 6 | -17.9 ± 7.8 | -19.7 ± 8.7 | -18.9 ± 8.2 | -19.5 ± 8.4 |
| Week 8 | -17.1 ± 7.4 | -19.4 ± 8.5 | -19.3 ± 8.7 | -21.1 ± 7.1 |
No statistical analysis provided for Change From Baseline in Seated Trough Cuff DBP
| 34. Secondary: | DBP Control [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | DBP Control |
| Measure Description | Percentage of responders (DBP<90 mmHg) for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
DBP Control
[units: percentage of participants] |
69.4 | 77.1 | 68.9 | 85 |
No statistical analysis provided for DBP Control
| 35. Secondary: | DBP Response [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | DBP Response |
| Measure Description | Percentage of responders (DBP<90 mmHg or >=10 mmHg reduction) for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
DBP Response
[units: percentage of participants] |
81.5 | 89.6 | 87.7 | 93 |
No statistical analysis provided for DBP Response
| 36. Secondary: | SBP Response [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | SBP Response |
| Measure Description | Percentage of responders (SBP<140 mmHg or >=10 mmHg reduction) for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
SBP Response
[units: percentage of participants] |
88.9 | 96.9 | 84.9 | 95 |
No statistical analysis provided for SBP Response
| 37. Secondary: | BP Control [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | BP Control |
| Measure Description | Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
BP Control
[units: percentage of participants] |
53.7 | 70.8 | 58.5 | 77 |
No statistical analysis provided for BP Control
| 38. Secondary: | BP Normality [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | BP Normality |
| Measure Description | Category based on both SBP and DBP (mmHg) for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
BP Normality
[units: percentage of participants] |
||||
| No (SBP>=140 and/or DBP>=90) | 46.3 | 29.2 | 41.5 | 23 |
| High Normal (140>SBP>=130 and 90>DBP>=85) | 25.9 | 29.2 | 26.4 | 27 |
| Normal (130>SBP>=120 and 85>DBP>=80) | 18.5 | 30.2 | 21.7 | 41 |
| Optimal (SBP<120 and DBP<80) | 9.3 | 11.5 | 10.4 | 9 |
No statistical analysis provided for BP Normality
| 39. Secondary: | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP |
| Measure Description | Observed results for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | monotherapy (A5 titrated to A10) |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
[units: mmHg] Mean ± Standard Deviation |
||||
| Hour 1 | -11 ± 10.8 | -16.9 ± 10.8 | -13.8 ± 10.1 | -13.7 ± 10.3 |
| Hour 2 | -8.8 ± 12.3 | -16.3 ± 12.5 | -13.9 ± 9.3 | -15.9 ± 13 |
| Hour 3 | -11.2 ± 14.4 | -13.8 ± 11.2 | -16.4 ± 11.3 | -16.1 ± 11.7 |
| Hour 4 | -10.7 ± 12.4 | -16.3 ± 13.6 | -15.9 ± 11.8 | -16.8 ± 11.3 |
| Hour 5 | -12.8 ± 10.5 | -15.3 ± 14.3 | -17.2 ± 14.3 | -16.6 ± 10.9 |
| Hour 6 | -10.5 ± 12.2 | -15.3 ± 12.6 | -15.2 ± 10.1 | -16.3 ± 11.8 |
| Hour 7 | -13.8 ± 11.1 | -15.3 ± 11.4 | -12.9 ± 10 | -17.5 ± 14.6 |
| Hour 8 | -13.3 ± 13.1 | -19.4 ± 13.7 | -13.5 ± 14.2 | -17.8 ± 13.7 |
| Hour 9 | -14 ± 11 | -16.6 ± 14.2 | -15.8 ± 14.3 | -18.1 ± 14.1 |
| Hour 10 | -10.7 ± 11.1 | -14.6 ± 14 | -17 ± 14.2 | -20.8 ± 13.2 |
| Hour 11 | -11.4 ± 13.9 | -14.8 ± 12.6 | -16.8 ± 10.5 | -17.9 ± 12.9 |
| Hour 12 | -12.4 ± 12.2 | -13.9 ± 12.4 | -14.3 ± 12.2 | -16.6 ± 12.9 |
| Hour 13 | -9.7 ± 13 | -14.9 ± 14.5 | -14.1 ± 12.5 | -15.9 ± 10.9 |
| Hour 14 | -8.5 ± 14.3 | -14.5 ± 14.6 | -15.1 ± 11.2 | -12 ± 14.6 |
| Hour 15 | -10.5 ± 16.6 | -10.5 ± 13.6 | -13.8 ± 14.7 | -10 ± 12.9 |
| Hour 16 | -10.9 ± 15 | -10.3 ± 16.3 | -12.8 ± 12.2 | -13.7 ± 13 |
| Hour 17 | -10.1 ± 14.1 | -9.8 ± 14.9 | -11.5 ± 12.5 | -12.3 ± 10.8 |
| Hour 18 | -11.8 ± 15.6 | -9.9 ± 13.5 | -10.6 ± 10.3 | -12.8 ± 10.8 |
| Hour 19 | -9 ± 11.7 | -11.6 ± 13.9 | -12.2 ± 10.6 | -12.5 ± 11.8 |
| Hour 20 | -10 ± 12.3 | -10.9 ± 13.1 | -13.3 ± 11.2 | -15.7 ± 11.5 |
| Hour 21 | -10.5 ± 12.3 | -8.6 ± 14.3 | -8.4 ± 12.1 | -15.1 ± 9.4 |
| Hour 22 | -10.9 ± 11.3 | -10 ± 14.6 | -10.2 ± 13.5 | -15.2 ± 10.2 |
| Hour 23 | -10 ± 11.8 | -14 ± 13.8 | -10 ± 12.5 | -14.3 ± 8.5 |
| Hour 24 | -9.7 ± 9.8 | -13.6 ± 11.2 | -13.2 ± 13.8 | -14.4 ± 12.2 |
No statistical analysis provided for Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
| 40. Secondary: | Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM 24-hour Mean DBP |
| Measure Description | Observed results for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
41 | 41 | 46 | 41 |
|
Change From Baseline in ABPM 24-hour Mean DBP
[units: mmHg] Mean ± Standard Deviation |
-11 ± 7.7 | -13.6 ± 8 | -13.6 ± 7.1 | -15.3 ± 7 |
No statistical analysis provided for Change From Baseline in ABPM 24-hour Mean DBP
| 41. Secondary: | Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in ABPM 24-hour Mean SBP |
| Measure Description | Observed results for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
41 | 41 | 46 | 41 |
|
Change From Baseline in ABPM 24-hour Mean SBP
[units: mmHg] Mean ± Standard Deviation |
-16.7 ± 11.3 | -20.8 ± 14.1 | -20.9 ± 11 | -22.7 ± 9.9 |
No statistical analysis provided for Change From Baseline in ABPM 24-hour Mean SBP
| 42. Secondary: | Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Orthostatic Change in Trough Cuff Mean DBP |
| Measure Description | Calculated as seated minus standing for mod-sev patients - key combination therapies |
| Time Frame | Week 8 |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
102 | 87 | 99 | 88 |
|
Orthostatic Change in Trough Cuff Mean DBP
[units: mmHg] Mean ± Standard Deviation |
2.5 ± 5.1 | 2 ± 5.7 | 1.4 ± 5.3 | 1.6 ± 4.5 |
No statistical analysis provided for Orthostatic Change in Trough Cuff Mean DBP
| 43. Secondary: | Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Orthostatic Change in Trough Cuff Mean SBP |
| Measure Description | Calculated as seated minus standing for mod-sev patients - key combination therapies |
| Time Frame | Week 8 |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
102 | 87 | 99 | 88 |
|
Orthostatic Change in Trough Cuff Mean SBP
[units: mmHg] Mean ± Standard Deviation |
0 ± 7.1 | 1.4 ± 8.1 | 0.1 ± 6.9 | 1.1 ± 6.3 |
No statistical analysis provided for Orthostatic Change in Trough Cuff Mean SBP
| 44. Secondary: | Change From Baseline in Seated Trough Pulse Rate [ Time Frame: Up to 8 weeks (LOCF) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Change From Baseline in Seated Trough Pulse Rate |
| Measure Description | Observed results for mod-sev patients - key combination therapies |
| Time Frame | Up to 8 weeks (LOCF) |
| Safety Issue |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | No text entered. |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | No text entered. |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | No text entered. |
Measured Values
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
108 | 96 | 106 | 100 |
|
Change From Baseline in Seated Trough Pulse Rate
[units: bpm] Mean ± Standard Deviation |
0.5 ± 8.8 | 0 ± 9 | 2.5 ± 9.2 | -1.9 ± 8.9 |
No statistical analysis provided for Change From Baseline in Seated Trough Pulse Rate
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00281580 History of Changes |
| Other Study ID Numbers: | 1235.1, 2008-000874-19 |
| Study First Received: | January 24, 2006 |
| Results First Received: | November 18, 2009 |
| Last Updated: | July 17, 2012 |
| Health Authority: | Argentina: Brazil: Mexico: South Africa: United States: Food and Drug Administration |