A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
NCT ID: NCT00785512
Last Updated: 2010-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
207 participants
INTERVENTIONAL
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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
2
Matching placebo tablets, oral administration
Placebo
Matching placebo tablets, oral administration
Interventions
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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
Placebo
Matching placebo tablets, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Forest Research Institute, a subsidiary of Forest Laboratories Inc
Principal Investigators
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Tatjana Lukic, MD, MSc
Role: STUDY_DIRECTOR
Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
Locations
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Forest Investigative Site
Chandler, Arizona, United States
Forest Investigative Site
Phoenix, Arizona, United States
Forest Investigative Site
Los Angeles, California, United States
Forest Investigative Site
Bradenton, Florida, United States
Forest Investigative Site
Brooksville, Florida, United States
Forest Investigative Site
DeLand, Florida, United States
Forest Investigative Site
Hollywood, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Pembroke Pines, Florida, United States
Forest Investigative Site
St. Petersburg, Florida, United States
Forest Investigative Site
Auburn, Maine, United States
Forest Investigative Site
Cary, North Carolina, United States
Forest Investigative Site
Hickory, North Carolina, United States
Forest Investigative Site
Salisbury, North Carolina, United States
Forest Investigative Site
Wilmington, North Carolina, United States
Forest Investigative Site
Winston-Salem, North Carolina, United States
Forest Investigative Site
Cincinnati, Ohio, United States
Forest Investigative Site
Marion, Ohio, United States
Forest Investigative Site
Lancaster, Pennsylvania, United States
Forest Investigative Site
Mt. Pleasant, South Carolina, United States
Forest Investigative Site
Simpsonville, South Carolina, United States
Forest Investigative Site
New Tazewell, Tennessee, United States
Forest Investigative Site
Dallas, Texas, United States
Forest Investigative Site
Dallas, Texas, United States
Countries
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Other Identifiers
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NEB-MD-17
Identifier Type: -
Identifier Source: org_study_id