Phase 3
Completed N=820
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
Source: ClinicalTrials.gov NCT00777946 ↗Enrolled (actual)
820
Serious AEs
1.0%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) — -13.07; -10.54; -5.84 mm Hg
Summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) |
-13.07; -10.54; -5.84 | — |
| SECONDARY Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) |
-18.04; -14.43; -6.42 | — |
| SECONDARY Number of Participants With Serious Adverse Events and Adverse Events |
3; 4; 1; 85; 80; 59 | — |
| SECONDARY Percentage of Participants Achieving Blood Pressure Control |
65.5; 56.5; 31.5 | — |
| SECONDARY Percentage of Participants Achieving a Diastolic Blood Pressure Response |
83.6; 77.7; 51.5 | — |
| SECONDARY Percentage of Participants Achieving a Systolic Blood Pressure Response |
77.2; 69.7; 43.8 | — |
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 mean sitting Diastolic Blood Pressure (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 4
Exclusion Criteria
- Severe hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00777946). 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.