A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
(ARIES Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Astellas Pharma Inc

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder

Research Team

Use Central Contact

Principal Investigator

Astellas Pharma Global Development

Eligibility Criteria

Inclusion Criteria

Patient is willing and able to complete the micturition diary and questionnaires correctly

Patient has symptoms of overactive bladder for ≥ 3 months

Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period

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Treatment Details

Interventions

Mirabegron (Beta-3 Agonist)
Placebo (Drug)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Mirabegron 50 mgExperimental Treatment1 Intervention

Participants received mirabegron 50 mg tablets orally once a day for 12 weeks

Group II: Mirabegron 100 mgExperimental Treatment1 Intervention

Participants received mirabegron 100 m tablets, orally once a day for 12 weeks

Group III: PlaceboPlacebo Group1 Intervention

Participants received matching placebo tablets orally once a day for 12 weeks

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Who Is Running the Clinical Trial?

Astellas Pharma Inc

Lead Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

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