Nebivolol in Patients With Systolic Stage 2 Hypertension
NCT ID: NCT01057251
Last Updated: 2012-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
433 participants
INTERVENTIONAL
2010-03-31
2011-01-31
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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1
Nebivolol
5 mg, titrated to 20 mg, once daily oral administration
2
Placebo
5 mg or 20 mg once daily, oral administration
Interventions
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Nebivolol
5 mg, titrated to 20 mg, once daily oral administration
Placebo
5 mg or 20 mg once daily, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mean seated heart rate at least 60 bpm
* diagnosed systolic stage 2 hypertension
* unremarkable physical exam findings
Exclusion Criteria
* concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
* currently taking medication that cannot be stopped during the course of the study
* participating other clinical trials
* member of the study center personnel
* documented drug abuse
* contra indication to beta blocker
* abnormal lab finding
* poor compliance
* other conditions judged by investigator that is not suitable for the study
18 Years
64 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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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 008
Foley, Alabama, United States
Forest Investigative Site 021
Montgomery, Alabama, United States
Forest Investigative Site 006
Chino, California, United States
Forest Investigative Site 002
Long Beach, California, United States
Forest Investigative Site 004
Los Angeles, California, United States
Forest Investigative Site 020
Temecula, California, United States
Forest Investigative Site 028
Coral Gables, Florida, United States
Forest Investigative Site 014
Daytona Beach, Florida, United States
Forest Investigative Site 001
Fort Lauderdale, Florida, United States
Forest Investigative Site 037
Fort Lauderdale, Florida, United States
Forest Investigative Site 033
Hialeah, Florida, United States
Forest Investigative Site 026
Jacksonville, Florida, United States
Forest Investigative Site 017
Miami, Florida, United States
Forest Investigative Site 010
Miami, Florida, United States
Forest Investigative Site 030
Orlando, Florida, United States
Forest Investigative Site 009
Atlanta, Georgia, United States
Forest Investigative Site 031
Augusta, Georgia, United States
Forest Investigative Site 039
Meridian, Idaho, United States
Forest Investigative Site 007
Auburn, Maine, United States
Forest Investigative Site 038
Baltimore, Maryland, United States
Forest Investigative Site 011
Baltimore, Maryland, United States
Forest Investigative Site 029
Prince Frederick, Maryland, United States
Forest Investigative Site 023
Paw Paw, Michigan, United States
Forest Investigative Site 005
Florissant, Missouri, United States
Forest Investigative Site 041
Las Vegas, Nevada, United States
Forest Investigative Site 040
New York, New York, United States
Forest Investigative Site 012
Hickory, North Carolina, United States
Forest Investigative Site 027
Salisbury, North Carolina, United States
Forest Investigative Site 024
Harleysville, Pennsylvania, United States
Forest Investigative Site 013
Charleston, South Carolina, United States
Forest Investigative Site 035
Greenville, South Carolina, United States
Forest Investigative Site 018
Mt. Pleasant, South Carolina, United States
Forest Investigative Site 022
Simpsonville, South Carolina, United States
Forest Investigative Site 003
Memphis, Tennessee, United States
Forest Investigative Site 032
Corpus Christi, Texas, United States
Forest Investigative Site 025
Richmond, Virginia, United States
Countries
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References
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Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.
Other Identifiers
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NEB-MD-20
Identifier Type: -
Identifier Source: org_study_id
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