Phase 3
Completed N=1,461
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Source: ClinicalTrials.gov NCT00281580 ↗Enrolled (actual)
1,461
Serious AEs
0.5%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) — -13; -16.4; -16.2; -16.9 mmHg
Summary
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) |
-13; -16.4; -16.2; -16.9 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) |
-12.5; -16.8; -16.6; -17.2 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) |
-12.3; -14.9; -15.6; -18.6 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) |
-12.2; -15.3; -16.2; -19.3 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) |
-5.9; -13.2; -13.1; -13.6; -18; -15.7 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) |
-6.2; -13.8; -13.4; -14; -18.3; -15.9 | — |
| PRIMARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) |
-13.8; -13.4; -14; -18.3; -15.9; -19.3 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) |
-13.1; -16.8; -16.9; -17.7 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) |
-12.7; -17.3; -17.3; -18 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) |
-12.7; -16; -16.3; -19.2 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) |
-12.5; -16.4; -16.7; -19.7 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) |
-5.5; -13.9; -13.8; -13.9; -18.4; -15.8 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) |
-5.8; -14.4; -14.2; -14.1; -18.9; -15.9 | — |
| PRIMARY Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) |
-14.5; -14.2; -14.1; -18.9; -15.9; -19.7 | — |
| SECONDARY Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) |
-2.5; -15.1; -14.6; -14.3; -18.8; -21 | — |
| SECONDARY Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP |
-4.9; -10.4; -10; -11.1; -14.9; -13.1 | — |
| SECONDARY Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP |
-0.5; -13.2; -13.2; -12.9; -17.4; -18.9 | — |
| SECONDARY DBP Control |
69.4; 77.1; 68.9; 85 | — |
| SECONDARY DBP Response |
81.5; 89.6; 87.7; 93 | — |
| SECONDARY SBP Response |
88.9; 96.9; 84.9; 95 | — |
| SECONDARY BP Normality |
46.3; 29.2; 41.5; 23; 25.9; 29.2 | — |
| SECONDARY Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP |
-11; -16.9; -13.8; -13.7; -8.8; -16.3 | — |
| SECONDARY Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP |
-18.7; -20.2; -19.1; -17.5; -13.1; -22.0 | — |
| SECONDARY Change From Baseline in ABPM 24-hour Mean DBP |
-11; -13.6; -13.6; -15.3 | — |
| SECONDARY Change From Baseline in ABPM 24-hour Mean SBP |
-16.7; -20.8; -20.9; -22.7 | — |
| SECONDARY Orthostatic Change in Trough Cuff Mean DBP |
2.5; 2; 1.4; 1.6 | — |
| SECONDARY Orthostatic Change in Trough Cuff Mean SBP |
0; 1.4; 0.1; 1.1 | — |
| SECONDARY Change From Baseline in Seated Trough Pulse Rate |
0.5; 0; 2.5; -1.9 | — |
| SECONDARY Change From Baseline in Seated Trough Cuff Mean SBP |
-1.9; -15.6; -15.4; -15.4; -19; -22.1 | — |
| SECONDARY Change From Baseline in Standing Trough Cuff Mean DBP |
-4.2; -11.7; -10.9; -11.3; -15.1; -13.3 | — |
| SECONDARY Change From Baseline in Standing Trough Cuff Mean SBP |
1; -13.7; -13.6; -14; -16.2; -19.4 | — |
| SECONDARY Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) |
0.0; 0.3; 0.0; 0.1; 0.0; 0.3 | — |
Eligibility Criteria
Inclusion criteria
Main Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main
Exclusion criteria
Exclusion Criteria
- Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
- Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.
Data sourced from ClinicalTrials.gov (NCT00281580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.