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)

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

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Fedovapagon 2 mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the mean number of night-time voids	12 weeks
Change in mean patient reported nocturia bother score	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in mean functional bladder capacity	2 months
Change in International Prostate Symptom Score (IPSS)	4 weeks
Change in International Prostate Symptom Score (IPSS)	12 weeks
Change in N-QOL Score	4 weeks
Change in N-QOL Score	12 weeks
Number and type of Adverse Events	12 weeks

Collaborators and Investigators

• Sponsor: Vantia Ltd
• Investigators: Principal Investigator: Marc Gittelman, MD, FACS, South Florida Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: VA106483, fedovapagon, BPH, nocturia, EQUINOC
• Additional Relevant MeSH Terms: Pathologic Processes; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Nocturia
• Other Study ID Numbers: 483-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No