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



Status:Completed
Conditions:Hematology, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:March 2016
End Date:August 2017

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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)

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.

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:
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