Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

NCT ID: NCT01415531

Last Updated: 2013-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

641 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

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

2

Dose-matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-match placebo

Interventions

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Nebivolol

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

Intervention Type DRUG

Placebo

Dose-match placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatjana Lukic, MD, M. Sc.

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 065

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 067

Phoenix, Arizona, United States

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Forest Investigative Site 070

Phoenix, Arizona, United States

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Forest Investigative Site 049

Buena Park, California, United States

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Forest Investigative Site 034

Burbank, California, United States

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Forest Investigative Site 039

Costa Mesa, California, United States

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Forest Investigative Site 024

Fountain Valley, California, United States

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Forest Investigative Site 020

Fresno, California, United States

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Forest Investigative Site 021

Fresno, California, United States

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Forest Investigative Site 040

Greenbrae, California, United States

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Forest Investigative Site 047

La Mesa, California, United States

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Forest Investigative Site 073

Los Angeles, California, United States

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Forest Investigative Site 077

Roseville, California, United States

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Forest Investigative Site 060

San Bernardino, California, United States

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Forest Investigative Site 054

San Francisco, California, United States

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Forest Investigative Site 018

Spring Valley, California, United States

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Forest Investigative Site 028

Denver, Colorado, United States

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Forest Investigative Site 059

Brooksville, Florida, United States

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Forest Investigative Site 033

Fort Lauderdale, Florida, United States

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Forest Investigative Site 006

Hallandale, Florida, United States

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Forest Investigative Site 044

Longwood, Florida, United States

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Forest Investigative Site 001

Miami, Florida, United States

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Forest Investigative Site 012

Miami, Florida, United States

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Forest Investigative Site 032

Miami, Florida, United States

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Forest Investigative Site 055

Miami, Florida, United States

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Forest Investigative Site 045

Oviedo, Florida, United States

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Forest Investigative Site 031

St. Petersburg, Florida, United States

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Forest Investigative Site 009

Atlanta, Georgia, United States

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Forest Investigative Site 007

Chicago, Illinois, United States

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Forest Investigative Site 004

Morton, Illinois, United States

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Forest Investigative Site 072

Evansville, Indiana, United States

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Forest Investigative Site 069

Newburgh, Indiana, United States

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Forest Investigative Site 025

Augusta, Kansas, United States

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Forest Investigative Site 029

Louisville, Kentucky, United States

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Forest Investigative Site 068

Madisonville, Kentucky, United States

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Forest Investigative Site 061

Metairie, Louisiana, United States

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Forest Investigative Site 057

New Orleans, Louisiana, United States

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Forest Investigative Site 058

New Orleans, Louisiana, United States

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Forest Investigative Site 008

Lutherville, Maryland, United States

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Forest Investigative Site 062

Fall River, Massachusetts, United States

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Forest Investigative Site 075

Paw Paw, Michigan, United States

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Forest Investigative Site 019

Brooklyn Center, Minnesota, United States

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Forest Investigative Site 017

Chaska, Minnesota, United States

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Forest Investigative Site 038

Belzoni, Mississippi, United States

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Forest Investigative Site 035

Olive Branch, Mississippi, United States

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Forest Investigative Site 023

Las Vegas, Nevada, United States

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Forest Investigative Site 048

Las Vegas, Nevada, United States

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Forest Investigative Site 052

Las Vegas, Nevada, United States

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Forest Investigative Site 014

Elizabeth, New Jersey, United States

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Forest Investigative Site 051

Trenton, New Jersey, United States

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Forest Investigative Site 003

Asheboro, North Carolina, United States

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Forest Investigative Site 010

Charlotte, North Carolina, United States

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Forest Investigative Site 011

Raleigh, North Carolina, United States

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Forest Investigative Site 016

Raleigh, North Carolina, United States

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Forest Investigative Site 005

Wilmington, North Carolina, United States

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Forest Investigative Site 036

Winston-Salem, North Carolina, United States

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Forest Investigative Site 002

Columbus, Ohio, United States

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Forest Investigative Site 050

Norman, Oklahoma, United States

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Forest Investigative Site 030

Portland, Oregon, United States

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Forest Investigative Site 056

Downingtown, Pennsylvania, United States

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Forest Investigative Site 022

Pelzer, South Carolina, United States

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Forest Investigative Site 053

Beaumont, Texas, United States

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Forest Investigative Site 066

Boerne, Texas, United States

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Forest Investigative Site 076

Corpus Christi, Texas, United States

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Forest Investigative Site 037

Dallas, Texas, United States

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Forest Investigative Site 043

Haltom City, Texas, United States

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Forest Investigative Site 015

Houston, Texas, United States

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Forest Investigative Site 026

Houston, Texas, United States

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Forest Investigative Site 027

Houston, Texas, United States

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Forest Investigative Site 074

Houston, Texas, United States

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Forest Investigative Site 071

Orem, Utah, United States

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Forest Investigative Site 042

Sandy City, Utah, United States

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Forest Investigative Site 063

Norfolk, Virginia, United States

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Forest Investigative Site 064

Norfolk, Virginia, United States

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Forest Investigative Site 046

Port Orchard, Washington, United States

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Countries

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United States

Other Identifiers

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NEB-MD-28

Identifier Type: -

Identifier Source: org_study_id

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