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NCT00688688 · ClinicalTrials.gov registry record · Phase 3

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

A Phase 3 study, sponsored by Astellas Pharma.

Completed
Registry status
Phase 3
Development phase
2,792
Enrollment target

NCT00688688: Completed Phase 3 study, sponsored by Astellas Pharma.

NCT00688688 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 2,792 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00688688, a Phase 3 study, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 3
Development phase
2,792 participants
Enrollment target

Study Summary

The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Primary Outcome

An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.

Interventions

  • DRUG Mirabegron
  • DRUG Tolterodine
  • DRUG Placebo to Mirabegron
  • DRUG Placebo to Tolterodine

Trial Details

FieldValue
Enrollment Target 2,792 participants
Start Date 2008-04-25
Est. Completion 2010-05-06
Phase Phase 3
Astellas Pharma

165 total trials

What the finished NCT00688688 record still lists

NCT00688688 is an interventional study that assigns participants to a tested intervention. Its 2,792 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 (262% higher).

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

NCT00688688 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00688688 about?

NCT00688688 is a clinical study titled "Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder". The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

What is the current status of trial NCT00688688?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,792 participants. The study started on 2008-04-25. Estimated completion is 2010-05-06.

What interventions are being tested in trial NCT00688688?

The interventions under investigation include: Mirabegron (DRUG), Tolterodine (DRUG), Placebo to Mirabegron (DRUG), Placebo to Tolterodine (DRUG).

Who is sponsoring clinical trial NCT00688688?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00688688's enrollment target sits among peer trials

2,792 82nd of 2000 higher than 1,919 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 NCT00688688, the US trial registry maintained by the National Library of Medicine. NCT00688688 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.