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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which amlodipine besylate and benazepril synergistically lower blood pressure in severe hypertension?
How does the amlodipine-benazepril combination compare to monotherapy in managing resistant hypertension outcomes?
Which biomarkers correlate with improved systolic/diastolic response in angiotensin II receptor blocker and calcium channel blocker combinations?
What adverse event profiles differentiate amlodipine-benazepril combinations from standard antihypertensive regimens in elderly patients?
How do dihydropyridine calcium channel blockers and ACE inhibitors interact in optimizing vascular endothelial function in stage 3 hypertension?
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Novartis Pharmaceuticals🇺🇸East Hanover, New Jersey, United States