A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

Forest Laboratories1 site in 1 country207 target enrollmentNovember 2008

ConditionsHypertension

InterventionsNebivolol Placebo

DrugsNebivolol Placebo

Overview

Phase: Phase 4
Intervention: Nebivolol
Conditions: Hypertension
Sponsor: Forest Laboratories
Enrollment: 207
Locations: 1
Primary Endpoint: Trough Sitting Diastolic Blood Pressure
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

August 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

Eligibility Criteria

Inclusion Criteria

•male and female outpatients 18 to 79 years of age
•Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
•meet criteria for stage I or II hypertension
•currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria

•type 1 or type 2 diabetes
•secondary hypertension
•evidence of other concurrent disease or conditions that might interfere with the conduct of the study
•treatment with any investigational study drug within 30 days of Screening (Visit 1)
•have a history of hypersensitivity to nebivolol or other β-blockers

Arms & Interventions

1

Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Intervention: Nebivolol