A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

Phase 3 Completed 601 enrolled Novartis

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Timeline

Start: 2006-10
Primary completion: 2008-07
Completion: 2008-07

Publications

Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	300 mg	Oral
Subject	Hydrochlorothiazide	Unknown	12.5 mg	—
Subject	Hydrochlorothiazide	Unknown	25 mg	—
Subject	Valsartan	Small molecule	320 mg	Oral

A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

Summary

Timeline

Publications

Drugs

Indications