NCT01508026

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

A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,161 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage 1 Hypertension
• Stage 2 Hypertension

Interventions

Type	Name	Description
DRUG	Nebivolol and Valsartan 1	Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
DRUG	Nebivolol and Valsartan 2	Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
DRUG	Nebivolol and Valsartan 3	Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
DRUG	Nebivolol 1	Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
DRUG	Nebivolol 2	Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
DRUG	Valsartan 1	Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
DRUG	Valsartan 2	Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
DRUG	Placebo	Dose matched placebo, oral administration

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2012-01-11
• Last updated: 2014-04-25

Locations

413 sites across 1 country: United States