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

NCT02637960 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2018-10-31

No results posted yet for this study

Summary

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

Conditions

  • Nocturia

Interventions

DRUG

Fedovapagon 2 mg

One daily dose of 2 mg fedovapagon for 12 weeks

DRUG

Placebo

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

Sponsors & Collaborators

  • Vantia Ltd

    lead INDUSTRY

Principal Investigators

  • Marc Gittelman, MD, FACS · South Florida Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637960 on ClinicalTrials.gov