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

Vantia Ltd432 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

432

Conditions

Nocturia

Interventions

Fedovapagon 2 mgDRUG

One daily dose of 2 mg fedovapagon for 12 weeks

PlaceboDRUG

One daily dose of placebo (matched to fedovapagon) for 12 weeks

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (48)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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