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

Vantia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nocturia

Treatments: Drug: Fedovapagon 2 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02637960

483-013

Details and patient eligibility

About

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

Full 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.

Enrollment: 432 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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432 participants in 2 patient groups

Fedovapagon 2 mg

Experimental group

Description:

One daily dose of 2 mg fedovapagon for 12 weeks

Treatment:

Drug: Fedovapagon 2 mg

Placebo matched to fedovapagon

Experimental group

Description:

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

Treatment:

Drug: Placebo