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Beta-3 Adrenergic Agonist

Vibegron for Overactive Bladder

Phase 3
Waitlist Available
Research Sponsored by Urovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
Awards & highlights

Study Summary

This trial will evaluate the long-term safety of vibegron in men with OAB symptoms on other BPH medications. The study will last 52 weeks and builds on an earlier study.

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from signing of informed consent up to 21 days after the last dose of study drug (up to approximately 52 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with any Adverse Event
Number of Participants with any Clinically Significant Clinical Laboratory Value
Number of Participants with any Clinically Significant Vital Sign Assessment
Secondary outcome measures
Change from Baseline at Week 52 in the Average Number of Micturition Episodes per Day
Change from Baseline at Week 52 in the Average Number of Nocturia Episodes per Night
Change from Baseline at Week 52 in the Average Number of Urge Urinary Incontinence Episodes per Day in Participants with Incontinence at Study URO-901-3005 Baseline
+3 more

Side effects data

From 2019 Phase 3 trial • 506 Patients • NCT03583372
9%
Hypertension
7%
Urinary tract infection
5%
Dry mouth
5%
Nasopharyngitis
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Tolterodine ER 4 mg
Overall Vibegron 75 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: VibegronExperimental Treatment1 Intervention
Participants will receive 75 milligrams (mg) vibegron orally once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibegron
2018
Completed Phase 3
~3520

Find a Location

Who is running the clinical trial?

Urovant Sciences GmbHLead Sponsor
10 Previous Clinical Trials
3,988 Total Patients Enrolled
Rachael Jankowich, RN, MSNStudy DirectorUrovant Sciences
1 Previous Clinical Trials
1,105 Total Patients Enrolled
Study DirectorStudy DirectorUrovant Sciences
1,207 Previous Clinical Trials
489,404 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
2019. "Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04103450.
~49 spots leftby Apr 2025
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