A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
NCT ID: NCT00770861
Last Updated: 2011-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
277 participants
INTERVENTIONAL
2008-09-30
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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Nebivolol
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; 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 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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
Placebo
Matching placebo tablets, oral administration
Interventions
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Nebivolol
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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
* Are taking three or more antihypertensive agents
* Have uncontrolled or poorly controlled diabetes mellitus type I or type II
* Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
* Participation in any investigational study within 30 days of Screening (Visit 1).
* Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
18 Years
80 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., M.Sc.
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Locations
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Forest Investigative Site
Buena Park, California, United States
Forest Investigative Site
Chino, California, United States
Forest Investigative Site
Long Beach, California, United States
Forest Investigative Site
Los Angeles, California, United States
Forest Investigative Site
National City, California, United States
Forest Investigative Site
San Bernardino, California, United States
Forest Investigative Site
Temecula, California, United States
Forest Investigative Site
Tustin, California, United States
Forest Investigative Site
Coral Gables, Florida, United States
Forest Investigative Site FL2
Hialeah, Florida, United States
Forest Investigative Site
Hialeah, Florida, United States
Forest Investigative Site
Hialeah, Florida, United States
Forest Investigative Site
Kissimmee, 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
Pembroke Pines, Florida, United States
Forest Investigative Site
West Palm Beach, Florida, United States
Forest Investigative Site
Atlanta, Georgia, United States
Forest Investigative Site
Atlanta, Georgia, United States
Forest Investigative Site
New Windsor, New York, United States
Forest Investigative Site
The Bronx, New York, United States
Forest Investigative Site
Carrollton, Texas, United States
Forest Investigative Site
Corpus Christi, Texas, United States
Forest Investigative Site
Dallas, Texas, United States
Forest Investigative Site
El Paso, Texas, United States
Forest Investigative Site
San Antonio, Texas, United States
Forest Investigative Site
San Antonio, Texas, United States
Forest Investigative Site
Ponce, , Puerto Rico
Forest Investigative Site
Salinas, , Puerto Rico
Forest Investigative Site
Santurce, , Puerto Rico
Countries
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Other Identifiers
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NEB-MD-16
Identifier Type: -
Identifier Source: org_study_id
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