Nebivolol in Patients With Systolic Stage 2 Hypertension

NCT ID: NCT01057251

Last Updated: 2012-01-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

Brief Summary

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The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 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

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

5 mg, titrated to 20 mg, once daily oral administration

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5 mg or 20 mg once daily, oral administration

Interventions

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Nebivolol

5 mg, titrated to 20 mg, once daily oral administration

Intervention Type DRUG

Placebo

5 mg or 20 mg once daily, oral administration

Intervention Type DRUG

Other Intervention Names

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Bystolic

Eligibility Criteria

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Inclusion Criteria

* male of female, 18 to 64 years of age at screening
* mean seated heart rate at least 60 bpm
* diagnosed systolic stage 2 hypertension
* unremarkable physical exam findings

Exclusion Criteria

* high risk due to secondary hypertension or former stage 3 hypertension by JNC6
* concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
* currently taking medication that cannot be stopped during the course of the study
* participating other clinical trials
* member of the study center personnel
* documented drug abuse
* contra indication to beta blocker
* abnormal lab finding
* poor compliance
* other conditions judged by investigator that is not suitable for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Manfred Stapff, MD, PhD

Role: STUDY_DIRECTOR

Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

Locations

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Forest Investigative Site 008

Foley, Alabama, United States

Site Status

Forest Investigative Site 021

Montgomery, Alabama, United States

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Forest Investigative Site 006

Chino, California, United States

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Forest Investigative Site 002

Long Beach, California, United States

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Forest Investigative Site 004

Los Angeles, California, United States

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Forest Investigative Site 020

Temecula, California, United States

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Forest Investigative Site 028

Coral Gables, Florida, United States

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Forest Investigative Site 014

Daytona Beach, Florida, United States

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Forest Investigative Site 001

Fort Lauderdale, Florida, United States

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Forest Investigative Site 037

Fort Lauderdale, Florida, United States

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Forest Investigative Site 033

Hialeah, Florida, United States

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Forest Investigative Site 026

Jacksonville, Florida, United States

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Forest Investigative Site 017

Miami, Florida, United States

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Forest Investigative Site 010

Miami, Florida, United States

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Forest Investigative Site 030

Orlando, Florida, United States

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Forest Investigative Site 009

Atlanta, Georgia, United States

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Forest Investigative Site 031

Augusta, Georgia, United States

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Forest Investigative Site 039

Meridian, Idaho, United States

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Forest Investigative Site 007

Auburn, Maine, United States

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Forest Investigative Site 038

Baltimore, Maryland, United States

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Forest Investigative Site 011

Baltimore, Maryland, United States

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Forest Investigative Site 029

Prince Frederick, Maryland, United States

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Forest Investigative Site 023

Paw Paw, Michigan, United States

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Forest Investigative Site 005

Florissant, Missouri, United States

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Forest Investigative Site 041

Las Vegas, Nevada, United States

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Forest Investigative Site 040

New York, New York, United States

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Forest Investigative Site 012

Hickory, North Carolina, United States

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Forest Investigative Site 027

Salisbury, North Carolina, United States

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Forest Investigative Site 024

Harleysville, Pennsylvania, United States

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Forest Investigative Site 013

Charleston, South Carolina, United States

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Forest Investigative Site 035

Greenville, South Carolina, United States

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Forest Investigative Site 018

Mt. Pleasant, South Carolina, United States

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Forest Investigative Site 022

Simpsonville, South Carolina, United States

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Forest Investigative Site 003

Memphis, Tennessee, United States

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Forest Investigative Site 032

Corpus Christi, Texas, United States

Site Status

Forest Investigative Site 025

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.

Reference Type DERIVED
PMID: 23332366 (View on PubMed)

Other Identifiers

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NEB-MD-20

Identifier Type: -

Identifier Source: org_study_id

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