drugset / Trial / NCT00437645

Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

NCT00437645

Phase 3 Completed 1183 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

Timeline

Start
2007-01
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg Oral
Subject Amlodipine Other / unclassified 10 mg Oral
Subject Valsartan Small molecule 160 mg Oral