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A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

NCT ID: NCT00410514

Last Updated: 2014-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-08-31

Brief Summary

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This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

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Detailed Description

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Conditions

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Lower Urinary Tract Symptoms Bladder Outlet Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Mirabegron 50 mg

Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.

Group Type EXPERIMENTAL

Mirabegron

Intervention Type DRUG

oral

Mirabegron 100 mg

Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.

Group Type EXPERIMENTAL

Mirabegron

Intervention Type DRUG

oral

Interventions

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Mirabegron

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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YM178 Myrbetriq

Eligibility Criteria

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Inclusion Criteria

* Men 45 years of age or older
* Documented bladder outlet obstruction

Exclusion Criteria

* History of urinary retention
* Symptomatic and recurrent urinary tract infection (UTI)
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Tuscon, Arizona, United States

Site Status

Atherton, California, United States

Site Status

Culver City, California, United States

Site Status

Fresno, California, United States

Site Status

San Diego, California, United States

Site Status

Torrance, California, United States

Site Status

Middlebury, Connecticut, United States

Site Status

Tallahassee, Florida, United States

Site Status

Des Moines, Iowa, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Watertown, Massachusetts, United States

Site Status

Garden City, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Virginia Beach, Virginia, United States

Site Status

Victoria, British Columbia, Canada

Site Status

Victoria, British Columbia, Canada

Site Status

Winnipeg, Manitoba, Canada

Site Status

Saint John, New Brunswick, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Kitchener, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Chicoutimi, Quebec, Canada

Site Status

Chicoutimi, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Pointe-Claire, Quebec, Canada

Site Status

Sherbrooke, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.

Reference Type BACKGROUND
PMID: 23727415 (View on PubMed)

Other Identifiers

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178-CL-060

Identifier Type: -

Identifier Source: org_study_id

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