A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

Forest Laboratories75 sites in 1 country641 target enrollmentAugust 2011

ConditionsHypertension

InterventionsPlacebo Nebivolol

DrugsNebivolol Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Hypertension
Sponsor: Forest Laboratories
Enrollment: 641
Locations: 75
Primary Endpoint: Trough Seated Diastolic Blood Pressure (DBP)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

April 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female outpatients, of age 18 - 54 years
•Patients diagnosed with stage 1 or stage 2 essential hypertension
•Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria

•Secondary hypertension or severe hypertension
•History of Type 1 diabetes mellitus
•A medical contraindication to discontinuing a current antihypertensive therapy
•Clinically significant respiratory disease that prohibit use of a beta blocker

Arms & Interventions

2

Dose-matched placebo

Intervention: Placebo

1

Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

Intervention: Nebivolol

Outcomes

Primary Outcomes

Trough Seated Diastolic Blood Pressure (DBP)

Time Frame: Change from Baseline to Week 8

Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.