NCT00136851CompletedPhase 4
A 6-Week Multi-center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
Novartis Pharmaceuticals1 site in 1 country259 target enrollmentStarted: December 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 259
- Locations
- 1
- Primary Endpoint
- Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks
Study Overview
Brief Summary
This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of severe hypertension
Exclusion Criteria
- •Diastolic blood pressure (DBP) < 60 mm Hg
- •Serum potassium < 3.5 or > 5.5 mEq/L in the absence of all potassium supplements
- •Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks
Secondary Outcomes
- Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks
- Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks
- Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks
- Percentage of subjects with swelling in legs or arms after 4 and 6 weeks
Investigators
Study Sites (1)
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