Phase 3
Completed N=847
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone
Source: ClinicalTrials.gov NCT00778921 ↗Enrolled (actual)
847
Serious AEs
0.6%
Results posted
Mar 2011
Primary outcomePrimary: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study — -10.99; -8.95; -7.23 mm Hg
Summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study |
-10.99; -8.95; -7.23 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study |
-14.42; -11.01; -8.20 | — |
| SECONDARY Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group |
87; 99; 92 | — |
| SECONDARY Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)
Exclusion Criteria
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.3 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 (NCT00778921). 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.