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

Astellas

Status and phase: Completed; Phase 2

Conditions: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Treatments: Drug: Placebo; Drug: Mirabegron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410514

178-CL-060

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Mirabegron 50 mg

Experimental group

Description:

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

Treatment:

Drug: Mirabegron

Mirabegron 100 mg

Experimental group

Description:

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

Treatment:

Drug: Mirabegron