Phase 3
Completed N=1,254
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
Source: ClinicalTrials.gov NCT00797862 ↗Enrolled (actual)
1,254
Serious AEs
2.6%
Results posted
May 2011
Primary outcomePrimary: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks — -25.34; -17.94; -19.81 mmHg
Summary
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks |
-25.34; -17.94; -19.81 | — |
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 |
-27.37; -26.34; -25.52 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32 |
-12.96; -12.96; -11.62 | — |
| SECONDARY Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks |
-12.39; -8.37; -9.02 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24 |
-13.64; -13.22; -12.25 | — |
| SECONDARY Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints |
46.5; 22.8; 25.2; 65.9; 33.3; 40.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients ≥ 18 years of age
- Participants with essential hypertension:
- Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and < 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
- All participants must have a msSBP ≥ 150 mmHg and < 180 mmHg at Visit 2
- Written informed consent to participate in this study prior to any study procedures
Exclusion Criteria
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
- History of cardiovascular conditions
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00797862). 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.