Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

Phase 3 Completed 149 enrolled Hanmi Pharmaceutical Company Limited

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

Timeline

Start: 2009-05
Primary completion: 2010-03
Completion: 2010-03

Outcome

Met primary endpoint

paper Least-square mean reduction in SBP at 6 weeks (primary endpoint) was significantly greater in the combination group (36.5 mmHg vs. 31.6 mmHg; p = 0.0117). PMID 22035131 ↗

Publications

Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	—
Subject	Amlodipine	Other / unclassified	10 mg	—
Subject	Losartan	Other / unclassified	50 mg	—
Background	Hydrochlorothiazide	Unknown	12.5 mg	—