A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)

Summary

The primary objective of the study was to investigate the efficacy of mirabegron versus placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for BPH.

Timeline

Start

2016-01-25

Primary completion

2017-07-21

Completion

2017-07-21

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Mirabegron 50mg; p <0.001; least square mean difference -0.52 (95% CI -0.82 to -0.21); ANCOVA NCT02656173 ↗

registry analysis (superiority test); Placebo vs Mirabegron 50mg; p <0.001; least square mean difference -0.48 (95% CI -0.78 to -0.17); mixed model repeated measure NCT02656173 ↗

Publications

• Kakizaki H, Lee KS, Katou D, Yamamoto O, Sumarsono B, Uno S, Yamaguchi O. Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study. Adv Ther. 2021 Jan;38(1):739-757. doi: 10.1007/s12325-020-01517-5. Epub 2020 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	50 mg	Oral
Background	Tamsulosin	Other / unclassified	0.2 mg	Oral

Indications