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Beta-3 Adrenergic Agonist

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)

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 baseline; week 12
Awards & highlights
Pivotal Trial

Summary

This trial is testing vibegron, a medication that helps relax bladder muscles, in men who still have overactive bladder symptoms despite being treated for an enlarged prostate. The goal is to see if vibegron can reduce their frequent and urgent need to urinate.

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day
Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day
Secondary study objectives
Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night
Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline
Change From Baseline at Week 12 in the Average Volume Voided Per Micturition
+1 more

Side effects data

From 2022 Phase 3 trial • 276 Patients • NCT04103450
2%
COVID-19
1%
Atrial fibrillation
1%
Non-cardiac chest pain
1%
Cervical vertebral fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
28-Week Vibegron Group
52-Week Vibegron Group

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vibegron 75 mgExperimental Treatment1 Intervention
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally once daily for 24 weeks.
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
3,159 Total Patients Enrolled
Rachael Jankowich, RN, MSNStudy DirectorUrovant Sciences
1 Previous Clinical Trials
276 Total Patients Enrolled
Study DirectorStudy DirectorUrovant Sciences
1,280 Previous Clinical Trials
499,303 Total Patients Enrolled
~166 spots leftby Dec 2025
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