Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02637960

Recruitment Status : Completed

First Posted : December 22, 2015

Last Update Posted : October 31, 2018

Sponsor:

Information provided by (Responsible Party):

Vantia Ltd

Study Description

Brief Summary:

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

Condition or disease	Intervention/treatment	Phase
Nocturia	Drug: Fedovapagon 2 mg Drug: Placebo	Phase 2 Phase 3

Detailed Description:

Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH).

The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	432 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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)
Actual Study Start Date :	March 2016
Actual Primary Completion Date :	July 2017
Actual Study Completion Date :	August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Enlarged Prostate (BPH)

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fedovapagon 2 mg One daily dose of 2 mg fedovapagon for 12 weeks	Drug: Fedovapagon 2 mg One daily dose of 2 mg fedovapagon for 12 weeks
Experimental: Placebo matched to fedovapagon One daily dose of placebo (matched to fedovapagon) for 12 weeks	Drug: Placebo One daily dose of placebo (matched to fedovapagon) for 12 weeks

Outcome Measures

Primary Outcome Measures :

Change in the mean number of night-time voids [ Time Frame: 12 weeks ]
Change in mean patient reported nocturia bother score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

Change in the mean number of night-time voids [ Time Frame: 1 week ]
Change in the mean number of night-time voids [ Time Frame: 4 weeks ]
Change in mean patient reported nocturia bother score [ Time Frame: 1 week ]
Change in mean patient reported nocturia bother score [ Time Frame: 4 weeks ]
Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production [ Time Frame: 2 months ]
Change in mean functional bladder capacity [ Time Frame: 2 months ]
Change in International Prostate Symptom Score (IPSS) [ Time Frame: 4 weeks ]
Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]
Change in N-QOL Score [ Time Frame: 4 weeks ]
Change in N-QOL Score [ Time Frame: 12 weeks ]
Number and type of Adverse Events [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637960

Locations

Layout table for location information

United States, Alabama
Vantia Investigative Center
Anniston, Alabama, United States
United States, Arizona
Vantia Investigative Center
Goodyear, Arizona, United States
United States, California
Vantia Investigative Center
Lincoln, California, United States
Vantia Investigative Center
Murrieta, California, United States
Vantia Investigative Center
San Diego, California, United States
United States, Florida
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
Saint Petersburg, Florida, United States
Vantia Investigative Center
Tampa, Florida, United States
United States, Indiana
Vantia Investigative Center
Avon, Indiana, United States
United States, Kansas
Vantia Investigative Center
Topeka, Kansas, United States
Vantia Investigative Center
Wichita, Kansas, United States
United States, Maryland
Vantia Investigative Center
Greenbelt, Maryland, United States
United States, Montana
Vantia Investigative Center
Missoula, Montana, United States
United States, Nebraska
Vantia Investigative Center
Omaha, Nebraska, United States
United States, New Jersey
Vantia Investigative Center
Englewood, New Jersey, United States
Vantia Investigative Center
Lawrenceville, New Jersey, United States
United States, New Mexico
Vantia Investigative Center
Albuquerque, New Mexico, United States
United States, New York
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
United States, North Carolina
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
United States, Ohio
Vantia Investigative Center
Akron, Ohio, United States
United States, Rhode Island
Vantia Investigative Center
Warwick, Rhode Island, United States
United States, South Carolina
Vantia Investigative Center
Charleston, South Carolina, United States
Vantia Investigative Center
Greer, South Carolina, United States
Vantia Investigative Center
Mount Pleasant, South Carolina, United States
United States, Tennessee
Vantia Investigative Center
Bristol, Tennessee, United States
United States, Texas
Vantia Investigative Center
Dallas, Texas, United States
Vantia Investigative Center
Houston, Texas, United States
Vantia Investigative Center
San Antonio, Texas, United States
United States, Utah
Vantia Investigative Center
Clinton, Utah, United States
Vantia Investigative Center
Ogden, Utah, United States
Vantia Investigative Center
Salt Lake City, Utah, United States
United States, Virginia
Vantia Investigative Center
Richmond, Virginia, United States

Sponsors and Collaborators

Vantia Ltd

Investigators

Layout table for investigator information

Principal Investigator:	Marc Gittelman, MD, FACS	South Florida Medical Research

More Information

Layout table for additonal information

Responsible Party:	Vantia Ltd
ClinicalTrials.gov Identifier:	NCT02637960
Other Study ID Numbers:	483-013
First Posted:	December 22, 2015 Key Record Dates
Last Update Posted:	October 31, 2018
Last Verified:	October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Vantia Ltd:


VA106483, fedovapagon, BPH, nocturia, EQUINOC

Additional relevant MeSH terms:

Layout table for MeSH terms

Prostatic Hyperplasia Hyperplasia Nocturia Pathologic Processes	Prostatic Diseases Lower Urinary Tract Symptoms Urological Manifestations

To Top