NCT02637960

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

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	Fedovapagon 2 mg	One daily dose of 2 mg fedovapagon for 12 weeks
DRUG	Placebo	One daily dose of placebo (matched to fedovapagon) for 12 weeks

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2015-12-22
• Last updated: 2018-10-31

Locations

48 sites across 1 country: United States