Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

NCT00219024 ↗

Phase 3 Completed 2775 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)

Timeline

Start: 2004-08
Primary completion: 2005-06
Completion: 2005-06

Publications

Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	75 mg	—
Subject	Aliskiren	Small molecule	150 mg	—
Subject	Aliskiren	Small molecule	300 mg	—

Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

Summary

Timeline

Publications

Drugs

Indications