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Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

NCT03902080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1105

Last updated 2024-08-07

Study results available
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Summary

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

Conditions

Interventions

DRUG

Vibegron

oral administration

DRUG

Placebo

oral administration

Sponsors & Collaborators

  • Urovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Study Director · Urovant Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2023-06-15
Completion
2023-06-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Hungary
  • Lithuania
  • Poland
  • Portugal
  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT03902080 on ClinicalTrials.gov