drugset / Trial / NCT00841672

Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

NCT00841672

Phase 3 Completed 485 enrolled Novartis
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Timeline

Start
2009-01
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg Oral
Comparator Amlodipine Other / unclassified 10 mg Oral

Indications