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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants
[units: participants] |
46 | 42 | 130 | 135 | 44 | 46 | 44 | 47 | 143 | 129 | 48 | 146 | 142 | 50 | 140 | 129 | 1461 |
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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 |
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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)) ] |
| 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:
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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 |
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| 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 |