Nocturia
Conditions
Keywords
VA106483, fedovapagon, BPH, nocturia, EQUINOC
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.
Interventions
DRUGFedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
DRUGPlacebo
One daily dose of placebo (matched to fedovapagon) for 12 weeks
Sponsors
Vantia Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean number of night-time voids | 12 weeks |
| Change in mean patient reported nocturia bother score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 the mean number of night-time voids | 1 week |
| Change in N-QOL Score | 4 weeks |
| Number and type of Adverse Events | 12 weeks |
| Change in International Prostate Symptom Score (IPSS) | 4 weeks |
| Change in mean patient reported nocturia bother score | 1 week |
Countries
United States
Outcome results
None listed