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NCT01972841 · ClinicalTrials.gov registry record · Phase 3

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

A Phase 3 study, sponsored by Astellas Pharma Europe B.V..

Completed
Registry status
Phase 3
Development phase
3,527
Enrollment target

NCT01972841: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..

NCT01972841 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 3,527 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (357% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01972841, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..

COMPLETED
Registry status
Phase 3
Development phase
3,527 participants
Enrollment target

Study Summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Primary Outcome

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Interventions

  • DRUG Mirabegron
  • DRUG Solifenacin succinate
  • DRUG Placebo to match mirabegron
  • DRUG Placebo to match solifenacin succinate

Trial Details

FieldValue
Enrollment Target 3,527 participants
Start Date 2013-11-05
Est. Completion 2015-10-22
Phase Phase 3
Astellas Pharma Europe B.V.

12 total trials

What the finished NCT01972841 record still lists

NCT01972841 is an interventional study that assigns participants to a tested intervention. Its 3,527 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 (357% higher).

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

NCT01972841 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01972841 about?

NCT01972841 is a clinical study titled "This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder". The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

What is the current status of trial NCT01972841?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,527 participants. The study started on 2013-11-05. Estimated completion is 2015-10-22.

What interventions are being tested in trial NCT01972841?

The interventions under investigation include: Mirabegron (DRUG), Solifenacin succinate (DRUG), Placebo to match mirabegron (DRUG), Placebo to match solifenacin succinate (DRUG).

Who is sponsoring clinical trial NCT01972841?

This trial is sponsored by Astellas Pharma Europe B.V., which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01972841's enrollment target sits among peer trials

3,527 68th of 2000 higher than 1,933 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 NCT01972841, the US trial registry maintained by the National Library of Medicine. NCT01972841 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.