Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
- Registration Number
- NCT02637960
- Lead Sponsor
- Vantia Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 432
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo matched to fedovapagon Placebo One daily dose of placebo (matched to fedovapagon) for 12 weeks Fedovapagon 2 mg Fedovapagon 2 mg One daily dose of 2 mg fedovapagon for 12 weeks
- Primary Outcome Measures
Name Time Method Change in mean patient reported nocturia bother score 12 weeks Change in the mean number of night-time voids 12 weeks
- Secondary Outcome Measures
Name Time Method Change in mean patient reported nocturia bother score 4 weeks Number and type of Adverse Events 12 weeks Change in the mean number of night-time voids 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) 12 weeks Change in N-QOL Score 12 weeks
Trial Locations
- Locations (1)
Vantia Investigative Center
🇺🇸Richmond, Virginia, United States