drugset / Trial / NCT00170950

Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension

NCT00170950 ↗

Phase 3 Terminated 11506 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2003-10
Primary completion
2008-01
Completion
2008-05

Outcome

Met primary endpoint

Stopped: “The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.”

paper a relative risk reduction of 19.6% (hazard ratio, 0.80, 95% confidence interval [CI], 0.72 to 0.90; P<0.001). PMID 19052124 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg Oral
Subject Amlodipine Other / unclassified 10 mg Oral
Subject Benazepril Unknown 20 mg Oral
Subject Benazepril Unknown 40 mg Oral
Comparator Hydrochlorothiazide Unknown 12.5 mg Oral
Comparator Hydrochlorothiazide Unknown 25 mg Oral

Indications