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 |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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] |
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| 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)) ] |
Hide Outcome Measure 1| 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) ] |
| 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) ] |
| 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) ] |
| 5. Primary: | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study visit (LOCF) ] |
| 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) ] |
| 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) ] |
| 8. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| 9. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF) ] |
| 10. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 11. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 12. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 13. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 14. Primary: | Change From Baseline in Seated Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 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) ] |
| 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) ] |
| 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) ] |
| 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 ] |
| 19. Secondary: | DBP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| 20. Secondary: | DBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| 21. Secondary: | SBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| 22. Secondary: | BP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| 23. Secondary: | BP Normality [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] |
| 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) ] |
| 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) ] |
| 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) ] |
| 27. Secondary: | Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] |
| 28. Secondary: | Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] |
| 29. Secondary: | Change From Baseline in Seated Trough Pulse Rate [ Time Frame: End-of-study visit (LOCF) ] |
| 30. Secondary: | Change From Baseline in Seated Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 31. Secondary: | Change From Baseline in Standing Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 32. Secondary: | Change From Baseline in Standing Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 33. Secondary: | Change From Baseline in Seated Trough Cuff DBP [ Time Frame: Nominal week over the trial ] |
| 34. Secondary: | DBP Control [ Time Frame: Up to 8 weeks (LOCF) ] |
| 35. Secondary: | DBP Response [ Time Frame: Up to 8 weeks (LOCF) ] |
| 36. Secondary: | SBP Response [ Time Frame: Up to 8 weeks (LOCF) ] |
| 37. Secondary: | BP Control [ Time Frame: Up to 8 weeks (LOCF) ] |
| 38. Secondary: | BP Normality [ Time Frame: Up to 8 weeks (LOCF) ] |
| 39. Secondary: | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 40. Secondary: | Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 41. Secondary: | Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] |
| 42. Secondary: | Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] |
| 43. Secondary: | Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] |
| 44. Secondary: | Change From Baseline in Seated Trough Pulse Rate [ Time Frame: Up to 8 weeks (LOCF) ] |
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 |