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

Phase 3 Completed 4161 enrolled Forest Laboratories

RandomizedParallel-groupTriple-blindTreatment

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

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	Small molecule	160 mg	Oral
Subject	Valsartan	Small molecule	320 mg	Oral

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

Timeline

Publications

Drugs

Indications