Clinical trial · Interventional
A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
NCT00410514CI-TRIAL-00014185completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Outlet Obstruction | — | UNRESOLVED | — |
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirabegron | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Mirabegron 50 mg
- description
- Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
- interventionNames
- Drug: Mirabegron
- type
- EXPERIMENTAL
- label
- Mirabegron 100 mg
- description
- Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDNitti 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. PMID 23727415