Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone

Phase 3 Completed 1018 enrolled Novartis

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Timeline

Start: 2004-10
Primary completion: 2005-06
Completion: 2005-06

Outcome

Met primary endpoint

paper Statistically significantly greater reductions in mean SBP/DBP were observed in both amlodipine/valsartan combinations PMID 19192976 ↗

paper both p < 0.0001) compared to valsartan 160 mg (8.3/6.7 mmHg). PMID 19192976 ↗

Publications

Sinkiewicz W, Glazer RD, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin. 2009 Feb;25(2):315-24. doi: 10.1185/03007990802630588.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	—
Subject	Amlodipine	Other / unclassified	10 mg	—
Subject	Valsartan	Unknown	160 mg	—