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...
Date First Received: August 26, 2005
Last Updated: June 1, 2006
Verified by: Novartis, June 2006
Clinical Trial Phase: Phase 4 | Start Date: December 2004
Overall Status: Completed
Estimated Enrollment: 268
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
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 Authorship and Review
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