Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
(PILLAR Trial)

Recruiting in Palo Alto (17 mi)

+119 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Research Team

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc., Medical Affairs, Americas

Eligibility Criteria

Inclusion Criteria

Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary.

Subject is willing and able to complete the micturition diary and questionnaires correctly.

Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening.

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Treatment Details

Interventions

Mirabegron (Beta-3 Adrenergic Agonist)
Placebo (Drug)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MirabegronExperimental Treatment1 Intervention

Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.