Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00136851
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States