Nocturia Clinical Trial
Official title:
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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