Dose Range Finding Study of Fedovapagon in Men With Nocturia
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia
1 other identifier
interventional
358
1 country
56
Brief Summary
The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
Shorter than P25 for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 20, 2014
June 1, 2014
1 year
July 31, 2012
June 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the mean nocturnal urine voids
12 weeks
Secondary Outcomes (5)
Change in the mean nocturnal urine voids
4 weeks
Change in the mean time to first nocturnal void
4 weeks
Change in the mean time to first nocturnal void
12 weeks
Change in Nocturia-related quality of life (N-QOL)
4 weeks
Change in Nocturia-related quality of life (N-QOL)
12 weeks
Study Arms (4)
fedovapagon 1 mg
EXPERIMENTALOnce daily oral dose of 1 mg fedovapagon for 12 weeks
fedovapagon 2 mg
EXPERIMENTALOnce daily oral dose of 2 mg fedovapagon for 12 weeks
fedovapagon 4 mg
EXPERIMENTALOnce daily oral dose of 4 mg fedovapagon for 12 weeks
sugar pill
PLACEBO COMPARATOROnce daily oral dose of placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Males aged 55 or over
- History and/ or symptoms of Nocturia (2 - 5 voids per night)
- Generally well (concomitant illness / conditions well controlled)
- Serum sodium, potassium, chloride and bicarbonate within normal limits
- No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
- Prostate specific antigen (PSA) within the normal range or not considered clinically significant
- Ability to comply with the requirements of the study
- Written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantia Ltdlead
Study Sites (56)
Vantia Investigative Center
Birmingham, Alabama, United States
Vantia Investigative Center
Huntsville, Alabama, United States
Vantia Investigative Center
Mobile, Alabama, United States
Vantia Investigative Center
Glendale, Arizona, United States
Vantia Investigative Center
Tucson, Arizona, United States
Vantia Investigative Center
Anaheim, California, United States
Vantia Investigative Center
Long Beach, California, United States
Vantia Investigative Center
San Diego, California, United States
Vantia Investigative Center
Denver, Colorado, United States
Vantia Investigative Center
Englewood, Colorado, United States
Vantia Investigative Center
Milford, Connecticut, United States
Vantia Investigative Center
Aventura, Florida, United States
Vantia Investigative Center
Clearwater, Florida, United States
Vantia Investigative Center
Daytona Beach, Florida, United States
Vantia Investigative Center
DeLand, Florida, United States
Vantia Investigative Center
Naples, Florida, United States
Vantia Investigative Center
Ocala, Florida, United States
Vantia Investigative Center
St. Petersburg, Florida, United States
Vantia Investigative Center
Tampa, Florida, United States
Vantia Investigative Center
Coeur d'Alene, Idaho, United States
Vantia Investigative Center
Meridian, Idaho, United States
Vantia Investigative Center
Chicago, Illinois, United States
Vantia Investigative Center
Evansville, Indiana, United States
Vantia Investigative Center
Jeffersonville, Indiana, United States
Vantia Investigative Center
Paducah, Kentucky, United States
Vantia Investigative Center
Metairie, Louisiana, United States
Vantia Investigative Center
Greenbelt, Maryland, United States
Vantia Investigative Center
Rochester, Michigan, United States
Vantia Investigative Center
Edina, Minnesota, United States
Vantia Investigative Center
Omaha, Nebraska, United States
Vantia Investigative Center
Brick, New Jersey, 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
Brooklyn, New York, United States
Vantia Investigative Center
Endwell, New York, United States
Vantia Investigative Center
Garden City, New York, United States
Vantia Investigative Center
New York, New York, United States
Vantia Investigative Center
Poughkeepsie, New York, United States
Vantia Investigative Center
Concord, North Carolina, United States
Vantia Investigative Center
Raleigh, North Carolina, United States
Vantia Investigative Center
Winston-Salem, North Carolina, United States
Vantia Investigative Center
Cincinnati, Ohio, United States
Vantia Investigative Center
Bethany, Oklahoma, United States
Vantia Investigative Center
Bala-Cynwyd, Pennsylvania, United States
Vantia Investigative Center
Warwick, Rhode Island, United States
Vantia Investigative Center
Mytrle Beach, South Carolina, United States
Vantia Investigative Center
Dakota Dunes, South Dakota, United States
Vantia Investigative Center
Nashville, Tennessee, United States
Vantia Investigative Center
Dallas, Texas, United States
Vantia Investigative Center
Fort Worth, Texas, United States
Vantia Investigative Center
San Antonio, Texas, United States
Vantia Investigative Center
Richmond, Virginia, United States
Vantia Investigative Center
Virginia Beach, Virginia, United States
Vantia Investigative Center
Burien, Washington, United States
Vantia Investigative Center
Middleton, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM
Vantia Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 2, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
June 20, 2014
Record last verified: 2014-06