Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide

Phase 3 Completed 198 enrolled Novartis

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Recruiting in Germany only: This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose combination in hypertensive patients not responding to treatment with the free combination of Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of the core study can be treated with valsartan plus HCTZ in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.

Timeline

Start: 2006-07
Primary completion: 2006-12
Completion: 2006-12

Outcome

Met primary endpoint

paper This represented an additional decrease in MSDBP of 5.1 +/- 7.9 mmHg (p < 0.0001). PMID 17922981 ↗

Publications

Results Schweizer J, Hilsmann U, Neumann G, Handrock R, Klebs S. Efficacy and safety of valsartan 160/HCTZ 25 mg in fixed combination in hypertensive patients not controlled by candesartan 32 mg plus HCTZ 25 mg in free combination. Curr Med Res Opin. 2007 Nov;23(11):2877-85. doi: 10.1185/030079907x242539.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Candesartan	Unknown	32 mg	—
Subject	Valsartan	Unknown	160 mg	—
Background	Amlodipine	Other / unclassified	5 mg	—
Background	Hydrochlorothiazide	Unknown	25 mg	—