A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

August 19, 2010 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Forest Investigative Site
      • Phoenix, Arizona, United States, 85050
        • Forest Investigative Site
    • California
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34203
        • Forest Investigative Site
      • Brooksville, Florida, United States, 34613
        • Forest Investigative Site
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site
      • Hollywood, Florida, United States, 33021
        • Forest Investigative Site
      • Miami, Florida, United States, 33169
        • Forest Investigative Site
      • Miami, Florida, United States, 33014
        • Forest Investigative Site
      • Miami, Florida, United States, 33156
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site
      • St. Petersburg, Florida, United States, 33709
        • Forest Investigative Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Forest Investigative Site
      • Hickory, North Carolina, United States, 28601
        • Forest Investigative Site
      • Salisbury, North Carolina, United States, 28144
        • Forest Investigative Site
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Forest Investigative Site
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Forest Investigative Site
      • Simpsonville, South Carolina, United States, 29681
        • Forest Investigative Site
    • Tennessee
      • New Tazewell, Tennessee, United States, 37825
        • Forest Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site
      • Dallas, Texas, United States, 75234
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Nebivolol
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
Other Names:
  • Bystolic® (nebivolol)
Placebo Comparator: 2
Matching placebo tablets, oral administration
Drug: Placebo
Matching placebo tablets, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Sitting Diastolic Blood Pressure
Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.
From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Sitting Systolic Blood Pressure
Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)
Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.
From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Tatjana Lukic, MD, MSc, Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2010

Last Update Submitted That Met QC Criteria

August 19, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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