Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

Phase 3 Completed 818 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Timeline

Start: 2008-10
Primary completion: 2009-05
Completion: 2009-05

Outcome

Met primary endpoint

paper This represents additional mean reductions of 11.6/7.2 mmHg (300/10 mg) and 8.0/4.7 mmHg (300/5 mg) over aliskiren alone (both p < 0.0001). PMID 22303910 ↗

Publications

Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aliskiren	Small molecule	300 mg	Oral
Subject	Amlodipine	Other / unclassified	5 mg	Oral
Subject	Amlodipine	Other / unclassified	10 mg	Oral