drugset / Trial / NCT00542269

Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome

NCT00542269

Phase 4 Terminated 178 enrolled Novartis
RandomizedParallel-groupTriple-blindTreatment

Summary

This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.

Timeline

Start
2008-03
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg Oral
Subject Ramipril Small molecule 10 mg Oral
Background Amlodipine Other / unclassified 5 mg Oral
Background Amlodipine Other / unclassified 10 mg Oral

Indications