A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients
Overview
- Phase
- Phase 2
- Intervention
- Valsartan + amlodipine 40/2.5 mg
- Conditions
- Essential Hypertension
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1474
- Locations
- 1
- Primary Endpoint
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Valsartan + amlodipine 40/2.5 mg
Intervention: Valsartan + amlodipine 40/2.5 mg
Valsartan + amlodipine 40/5 mg
Intervention: Valsartan + amlodipine 40/5 mg
Valsartan + amlodipine 80/2.5 mg
Intervention: Valsartan + amlodipine 80/2.5 mg
Valsartan + amlodipine 80/5 mg
Intervention: Valsartan + amlodipine 80/5 mg
Valsartan 40 mg
Intervention: Valsartan 40 mg
Valsartan 80 mg
Intervention: Valsartan 80 mg
Amlodipine 2.5 mg
Intervention: Amlodipine 2.5 mg
Amlodipine 5 mg
Intervention: Amlodipine 5 mg
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
Time Frame: Baseline to end of study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Secondary Outcomes
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)(Baseline to end of study (Week 8))