Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Phase 4 Completed 443 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Timeline

Start: 2009-02
Primary completion: 2009-08
Completion: 2009-08

Publications

Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	150 mg	—
Subject	Aliskiren	Small molecule	300 mg	—
Comparator	Amlodipine	Other / unclassified	5 mg	—
Comparator	Amlodipine	Other / unclassified	10 mg	—

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Summary

Timeline

Publications

Drugs

Indications