Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder

Phase 2 Completed 260 enrolled Astellas Pharma Europe B.V.

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.

Timeline

Start: 2004-04-05
Primary completion: 2005-01-25
Completion: 2005-01-25

Outcome

Met primary endpoint

paper Mirabegron 100 and 150 mg BID resulted in a statistically significant improvement versus placebo PMID 23424164 ↗

paper in the primary endpoint of micturition frequency (2.2 micturitions/24 hr vs. 1.2 micturitions/24 hr for both doses, adjusted P ≤ 0.01 for both comparisons). PMID 23424164 ↗

Publications

Chapple CR, Amarenco G, Lopez Aramburu MA, Everaert K, Liehne J, Lucas M, Vik V, Ridder A, Snijder R, Yamaguchi O; BLOSSOM Investigator Group. A proof-of-concept study: mirabegron, a new therapy for overactive bladder. Neurourol Urodyn. 2013 Nov;32(8):1116-22. doi: 10.1002/nau.22373. Epub 2013 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	100 mg	Oral
Subject	Mirabegron	Other / unclassified	150 mg	Oral
Comparator	Tolterodine	Unknown	4 mg	Oral