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NCT03492281 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Urovant Sciences.

Completed
Registry status
Phase 3
Development phase
1,530
Enrollment target

NCT03492281: Completed Phase 3 study, sponsored by Urovant Sciences.

NCT03492281 is a Phase 3 study that has completed, run by Urovant Sciences. The registered enrollment target is 1,530 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03492281, a Phase 3 study, has completed, sponsored by Urovant Sciences.

COMPLETED
Registry status
Phase 3
Development phase
1,530 participants
Enrollment target

Study Summary

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

Primary Outcome

A micturition/void is defined as "Urinated in Toilet" as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a participant voided in the toilet as indicated on the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was c

Interventions

  • DRUG Tolterodine Tartrate ER
  • DRUG vibegron
  • DRUG Vibegron placebo
  • DRUG Tolterodine placebo

Trial Details

FieldValue
Enrollment Target 1,530 participants
Start Date 2018-03-26
Est. Completion 2019-02-04
Phase Phase 3
Urovant Sciences

10 total trials

What the finished NCT03492281 record still lists

NCT03492281 is an interventional study that assigns participants to a tested intervention. Its 1,530 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% higher).

The record links to 0 conditions, and to 4 interventions - of which Tolterodine Tartrate ER is the first listed.

NCT03492281 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03492281 about?

NCT03492281 is a clinical study titled "A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)". This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

What is the current status of trial NCT03492281?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,530 participants. The study started on 2018-03-26. Estimated completion is 2019-02-04.

What interventions are being tested in trial NCT03492281?

The interventions under investigation include: Tolterodine Tartrate ER (DRUG), vibegron (DRUG), Vibegron placebo (DRUG), Tolterodine placebo (DRUG).

Who is sponsoring clinical trial NCT03492281?

This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03492281's enrollment target sits among peer trials

1,530 154th of 2000 higher than 1,846 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03492281, the US trial registry maintained by the National Library of Medicine. NCT03492281 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.