Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: amlodipine besylate/benazepril hydrochloride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeksChange 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: December 2004
Last updated: June 1, 2006
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