Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
NCT ID: NCT02637960
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
432 participants
INTERVENTIONAL
2016-03-31
2017-08-31
Brief Summary
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Detailed Description
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The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
Fedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
Placebo matched to fedovapagon
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Placebo
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Interventions
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Fedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
Placebo
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Benign prostatic hyperplasia
* Persistent nocturia despite previous lifestyle modification advice including appropriate fluid management
* Serum sodium not below lower limit of normal prior to randomization
* Provide signed and dated informed consent before any study-specific procedures are conducted.
* Able to comply with the requirements of the study.
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Vantia Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Gittelman, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
South Florida Medical Research
Locations
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Vantia Investigative Center
Anniston, Alabama, United States
Vantia Investigative Center
Goodyear, Arizona, United States
Vantia Investigative Center
Lincoln, California, United States
Vantia Investigative Center
Murrieta, California, United States
Vantia Investigative Center
San Diego, California, United States
Vantia Investigative Center
Aventura, Florida, United States
Vantia Investigative Center
Bradenton, Florida, United States
Vantia Investigative Center
Clearwater, Florida, United States
Vantia Investigative Center
Coral Gables, Florida, United States
Vantia Investigative Center
DeLand, Florida, United States
Vantia Investigative Center
Hialeah, Florida, United States
Vantia Investigative Center
Miami, Florida, United States
Vantia Investigative Center
Ocala, Florida, United States
Vantia Investigative Center
Pembroke Pines, Florida, United States
Vantia Investigative Center
St. Petersburg, Florida, United States
Vantia Investigative Center
Tampa, Florida, United States
Vantia Investigative Center
Avon, Indiana, United States
Vantia Investigative Center
Topeka, Kansas, United States
Vantia Investigative Center
Wichita, Kansas, United States
Vantia Investigative Center
Greenbelt, Maryland, United States
Vantia Investigative Center
Missoula, Montana, United States
Vantia Investigative Center
Omaha, Nebraska, United States
Vantia Investigative Center
Englewood, New Jersey, United States
Vantia Investigative Center
Lawrenceville, New Jersey, United States
Vantia Investigative Center
Albuquerque, New Mexico, United States
Vantia Investigative Center
Garden City, New York, United States
Vantia Investigative Center
New York, New York, United States
Vantia Investigative Center
Newburgh, New York, United States
Vantia Investigative Center
Poughkeepsie, New York, United States
Vantia Investigative Center
Cary, North Carolina, United States
Vantia Investigative Center
Concord, North Carolina, United States
Vantia Investigative Center
High Point, North Carolina, United States
Vantia Investigative Center
Raleigh, North Carolina, United States
Vantia Investigative Center
Wilmington, North Carolina, United States
Vantia Investigative Center
Winston-Salem, North Carolina, United States
Vantia Investigative Center
Akron, Ohio, United States
Vantia Investigative Center
Warwick, Rhode Island, United States
Vantia Investigative Center
Charleston, South Carolina, United States
Vantia Investigative Center
Greer, South Carolina, United States
Vantia Investigative Center
Mt. Pleasant, South Carolina, United States
Vantia Investigative Center
Bristol, Tennessee, United States
Vantia Investigative Center
Dallas, Texas, United States
Vantia Investigative Center
Houston, Texas, United States
Vantia Investigative Center
San Antonio, Texas, United States
Vantia Investigative Center
Clinton, Utah, United States
Vantia Investigative Center
Ogden, Utah, United States
Vantia Investigative Center
Salt Lake City, Utah, United States
Vantia Investigative Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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483-013
Identifier Type: -
Identifier Source: org_study_id
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