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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Nocturia

Intervention / Treatment
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* Drug: Fedovapagon 2 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fedovapagon 2 mg<br>One daily dose of 2 mg fedovapagon for 12 weeks | Drug: Fedovapagon 2 mg<br>* One daily dose of 2 mg fedovapagon for 12 weeks<br>|
| Experimental: Placebo matched to fedovapagon<br>One daily dose of placebo (matched to fedovapagon) for 12 weeks | Drug: Placebo<br>* One daily dose of placebo (matched to fedovapagon) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean number of night-time voids |  | 12 weeks | 
| Change in mean patient reported nocturia bother score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean number of night-time voids |  | 1 week | 
| Change in the mean number of night-time voids |  | 4 weeks | 
| Change in mean patient reported nocturia bother score |  | 1 week | 
| Change in mean patient reported nocturia bother score |  | 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) |  | 4 weeks | 
| Change in International Prostate Symptom Score (IPSS) |  | 12 weeks | 
| Change in N-QOL Score |  | 4 weeks | 
| Change in N-QOL Score |  | 12 weeks | 
| Number and type of Adverse Events |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VA106483, fedovapagon, BPH, nocturia, EQUINOC