Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
EQUINOC
A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)
1 other identifier
interventional
432
1 country
48
Brief Summary
This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2016
Shorter than P25 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 31, 2018
October 1, 2018
1.3 years
December 17, 2015
October 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in the mean number of night-time voids
12 weeks
Change in mean patient reported nocturia bother score
12 weeks
Secondary Outcomes (11)
Change in the mean number of night-time voids
1 week
Change in the mean number of night-time voids
4 weeks
Change in mean patient reported nocturia bother score
1 week
Change in mean patient reported nocturia bother score
4 weeks
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production
2 months
- +6 more secondary outcomes
Study Arms (2)
Fedovapagon 2 mg
EXPERIMENTALOne daily dose of 2 mg fedovapagon for 12 weeks
Placebo matched to fedovapagon
EXPERIMENTALOne daily dose of placebo (matched to fedovapagon) for 12 weeks
Interventions
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Eligibility Criteria
You may qualify if:
- Adult males ≥18 years \[no upper limit\]
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantia Ltdlead
Study Sites (48)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gittelman, MD, FACS
South Florida Medical Research
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
December 17, 2015
First Posted
December 22, 2015
Study Start
March 1, 2016
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
October 31, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share