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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00785512
First received: November 3, 2008
Last updated: August 19, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Nebivolol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Trough Sitting Diastolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ] [ Designated as safety issue: No ]
    Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.


Secondary Outcome Measures:
  • Trough Sitting Systolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ] [ Designated as safety issue: No ]
    Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.


Enrollment: 207
Study Start Date: November 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bystolic® (nebivolol)
Placebo Comparator: 2
Matching placebo tablets, oral administration
 Drug: Placebo
Matching placebo tablets, oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785512

Locations
United States, Arizona
Forest Investigative Site
Chandler, Arizona, United States, 85225
Forest Investigative Site
Phoenix, Arizona, United States, 85050
United States, California
Forest Investigative Site
Los Angeles, California, United States, 90057
United States, Florida
Forest Investigative Site
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, 33156
Forest Investigative Site
Miami, Florida, United States, 33014
Forest Investigative Site
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site
St. Petersburg, Florida, United States, 33709
United States, Maine
Forest Investigative Site
Auburn, Maine, United States, 04210
United States, North Carolina
Forest Investigative Site
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
United States, Ohio
Forest Investigative Site
Cincinnati, Ohio, United States, 45242
Forest Investigative Site
Marion, Ohio, United States, 43302
United States, Pennsylvania
Forest Investigative Site
Lancaster, Pennsylvania, United States, 17601
United States, South Carolina
Forest Investigative Site
Mt. Pleasant, South Carolina, United States, 29464
Forest Investigative Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Forest Investigative Site
New Tazewell, Tennessee, United States, 37825
United States, Texas
Forest Investigative Site
Dallas, Texas, United States, 75234
Forest Investigative Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Tatjana Lukic, MD, MSc Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
  More Information

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc
ClinicalTrials.gov Identifier: NCT00785512     History of Changes
Other Study ID Numbers: NEB-MD-17
Study First Received: November 3, 2008
Results First Received: August 19, 2010
Last Updated: August 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
nebivolol
Bystolic®
Hypertension
blood pressure
withdrawal

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013