NCT01218100

Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

Conditions

• Stage 2 Diastolic Hypertension

Interventions

Type	Name	Description
DRUG	nebivolol and lisinopril (free combination)	nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks
DRUG	nebivolol monotherapy	nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only) nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks
DRUG	lisinopril monotherapy	lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks
DRUG	placebo	Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2010-10-11
• Last updated: 2012-06-21
• Results posted: 2012-06-21

Locations

90 sites across 2 countries: United States, Puerto Rico