A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Phase 3 Completed 881 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

Timeline

Start: 2006-09
Primary completion: 2007-07
Completion: 2007-07

Publications

Results Nickenig G, Simanenkov V, Lembo G, Rodriguez P, Salko T, Ritter S, Zhang J. Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders. Blood Press Suppl. 2008 Dec;2:31-40. doi: 10.1080/08038020802507290.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	300 mg	—
Subject	Hydrochlorothiazide	Unknown	12.5 mg	—
Subject	Hydrochlorothiazide	Unknown	25 mg	—

A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Summary

Timeline

Publications

Drugs

Indications