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A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

NCT03492281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1530

Last updated 2021-03-04

Study results available
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Summary

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Conditions

Interventions

DRUG

vibegron

single daily oral dose of vibegron 75 mg for 12 weeks

DRUG

Vibegron placebo

placebo to match vibegron (experimental drug)

DRUG

Tolterodine Tartrate ER

single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks

DRUG

Tolterodine placebo

placebo to match tolterodine (active comparator)

Sponsors & Collaborators

  • Urovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-01-10
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hungary
  • Latvia
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

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 NCT03492281 on ClinicalTrials.gov