Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients
NCT ID: NCT00734630
Last Updated: 2011-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
491 participants
INTERVENTIONAL
2008-08-31
2010-05-31
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 nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
nebivolol
Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Placebo
Matching placebo tablets, oral administration
Placebo
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Interventions
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nebivolol
Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Placebo
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a history of hypertension
* Qualifying laboratory results
Exclusion Criteria
* Documented congestive heart failure
* Have clinically significant respiratory, liver, or heart disease
* History of stroke, heart attack, or heart surgery in the last 6 months
* Have a history of hypersensitivity to nebivolol or other beta blockers.
18 Years
85 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Forest Research Institute, a Subsidairy of Forest Laboratories, Inc.
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 070
Gulf Shores, Alabama, United States
Forest Investigative Site 092
Huntsville, Alabama, United States
Forest Investigative Site 058
Mesa, Arizona, United States
Forest Investigative Site 059
Tempe, Arizona, United States
Forest Investigative Site 024
Anaheim, California, United States
Forest Investigative Site 012
Bell Gardens, California, United States
Forest Investigative Site 026
Chino, California, United States
Forest Investigative Site 083
Costa Mesa, California, United States
Forest Investigative Site 030
Los Angeles, California, United States
Forest Investigative Site 053
Orange, California, United States
Forest Investigative Site 077
Riverside, California, United States
Forest Investigative Site 034
Sacramento, California, United States
Forest Investigative Site 028
Sacramento, California, United States
Forest Investigative Site 048
San Bernardino, California, United States
Forest Investigative Site 075
Santa Ana, California, United States
Forest Investigative Site 087
Santa Ana, California, United States
Forest Investigative Site 090
Temecula, California, United States
Forest Investigative Site 010
Tustin, California, United States
Forest Investigative Site 001
Westlake Village, California, United States
Forest Investigative Site 061
Wheat Ridge, Colorado, United States
Forest Investigative Site 046
Brooksville, Florida, United States
Forest Investigative Site 015
DeLand, Florida, United States
Forest Investigative Site 035
Fort Lauderdale, Florida, United States
Forest Investigative Site 009
Hialeah, Florida, United States
Forest Investigative Site 039
Hollywood, Florida, United States
Forest Investigative Site 044
Jacksonville, Florida, United States
Forest Investigative Site 002
Miami, Florida, United States
Forest Investigative Site 085
Miami, Florida, United States
Forest Investigative Site 091
Miami, Florida, United States
Forest Investigative Site 013
Miami, Florida, United States
Forest Investigative Site 052
Miami, Florida, United States
Forest Investigative Site 049
Orlando, Florida, United States
Forest Investigative Site 065
Pembroke Pines, Florida, United States
Forest Investigative Site 041
Tampa, Florida, United States
Forest Investigative Site 029
Atlanta, Georgia, United States
Forest Investigative Site 068
Decatur, Georgia, United States
Forest Investigative Site 050
Addison, Illinois, United States
Forest Investigative Site 025
Chicago, Illinois, United States
Forest Investigative Site 057
Chicago, Illinois, United States
Forest Investigative Site 076
Joliet, Illinois, United States
Forest Investigative Site 014
Orland Park, Illinois, United States
Forest Investigative Site 079
Overland Park, Kansas, United States
Forest Investigative Site 037
Auburn, Maine, United States
Forest Investigative Site 045
Biddeford, Maine, United States
Forest Investigative Site 003
Oxon Hill, Maryland, United States
Forest Investigative Site 060
Prince Frederick, Maryland, United States
Forest Investigative Site 042
Reisterstown, Maryland, United States
Forest Investigative Site 023
Brockton, Massachusetts, United States
Forest Investigative Site 066
Brockton, Massachusetts, United States
Forest Investigative Site 040
Saint Clair Shores, Michigan, United States
Forest Investigative Site 067
Rolling Fork, Mississippi, United States
Forest Investigative Site 051
Edison, New Jersey, United States
Forest Investigative Site 088
New York, New York, United States
Forest Investigative Site 086
Syracuse, New York, United States
Forest Investigative Site 006
Cary, North Carolina, United States
Forest Investigative Site 022
Charlotte, North Carolina, United States
Forest Investigative Site 064
Harrisburg, North Carolina, United States
Forest Investigative Site 071
Raleigh, North Carolina, United States
Forest Investigative Site 017
Wilmington, North Carolina, United States
Forest Investigative Site 055
Fargo, North Dakota, United States
Forest Investigative Site 007
Cincinnati, Ohio, United States
Forest Investigative Site 054
Cleveland, Ohio, United States
Forest Investigative Site 056
Perrysburg, Ohio, United States
Forest Investigative Site 080
Ashland, Oregon, United States
Forest Investigative Site 033
Eugene, Oregon, United States
Forest Investigative Site 081
Harleysville, Pennsylvania, United States
Forest Investigative Site 004
Greenville, South Carolina, United States
Forest Investigative Site 031
Mt. Pleasant, South Carolina, United States
Forest Investigative Site 018
Cleveland, Tennessee, United States
Forest Investigative Site 043
Memphis, Tennessee, United States
Forest Investigative Site 032
Nashville, Tennessee, United States
Forest Investigative Site 008
Corpus Christi, Texas, United States
Forest Investigative Site 063
San Antonio, Texas, United States
Forest Investigative Site 062
San Antonio, Texas, United States
Forest Investigative Site 016
Richmond, Virginia, United States
Countries
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References
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Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.
Other Identifiers
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NEB-MD-11
Identifier Type: -
Identifier Source: org_study_id
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