Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
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...
Brief Summary
Official Title: “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”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: July 2005
Intervention(s) in this Clinical Trial
- Drug: amlodipine besylate/benazepril hydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Clinical Trial Investigator Information
Lead Investigator: Novartis Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00136851
Study ID Number: CCIB002FUS19
ClinicalTrials.gov Identifier: NCT00136851
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00136851
