NCT01656239

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia. The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria). The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	fedovapagon 1 mg
DRUG	fedovapagon 2 mg
DRUG	fedovapagon 4 mg
DRUG	Placebo ( sugar pill)

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-08-02
• Last updated: 2014-06-20

Locations

56 sites across 1 country: United States