A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population...
Date First Received: September 10, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 3 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 11464
Brief Summary
Official Title: “A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension”
Condition Keyword(s):
Intervention(s):
A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Benazepril/amlodipine
Outcome Measures for this Clinical Trial
Primary Measures
- Time to having a cardiovascular or neurologic event, including: death from a cardiovascular event, heart attack,
- stroke, hospitalization for chest pain or heart failure, or
- procedure to open a blockage in an arterial blood vessel
Secondary Measures
- Time to having a cardiovascular or neurologic event, including: death from a cardiovascular event, heart attack,
- stroke, or hospitalization for heart failure or or
- procedure to open a blockage in an arterial blood vessel
- Risk of developing diabetes
- Progression of kidney disease
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- At least 55 years of age.
- Have elevated blood pressure and at least one other cardiovascular disease or diabetes or evidence of damage to the kidneys, brain, blood vessels or heart as defined in the protocol
Exclusion Criteria:
- Allergy to any of the drugs administered in this trial. Selected laboratory tests.
- Other protocol-defined exclusion criteria may apply.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 55 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00170950
Study ID Number: CCIB002I2301
ClinicalTrials.gov Identifier: NCT00170950
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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