Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

Summary

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Timeline

Start

2012-01

Primary completion

2013-03

Completion

2013-05

Outcome

Met primary endpoint

paper the fixed-dose combination 20 and 320 mg/day group had significantly greater reductions in diastolic blood pressure from baseline than both nebivolol 40 mg/day PMID 24881993 ↗

paper least-squares mean difference -1·2 mm Hg, 95% CI -2·3 to -0·1; p=0·030 PMID 24881993 ↗

Publications

• Giles TD, Weber MA, Basile J, Gradman AH, Bharucha DB, Chen W, Pattathil M; NAC-MD-01 Study Investigators. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. Lancet. 2014 May 31;383(9932):1889-98. doi: 10.1016/S0140-6736(14)60614-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nebivolol	Other / unclassified	10 mg	Oral
Subject	Nebivolol	Other / unclassified	20 mg	Oral
Subject	Nebivolol	Other / unclassified	40 mg	Oral
Subject	Valsartan	Unknown	160 mg	Oral
Subject	Valsartan	Unknown	320 mg	Oral

Indications