Conditions: Urinary Bladder, Overactive
Keywords: Micturition Urinary incontinence Urinary urge incontinence Overactive bladder (OAB) Urgency YM178 Frequency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2336
Healthy volunteers: no

Brief summary:
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Detailed description:

Arms:
arm 1: Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks. arm 2: Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. arm 3: Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. arm 4: Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.

Interventions: intervention 1: Mirabegron intervention 2: Tolterodine intervention 3: Placebo to Mirabegron intervention 4: Placebo to Tolterodine
Intervention descriptions: intervention 1: Tablets intervention 2: Capsules intervention 3: Matching mirabegron placebo tablets. intervention 4: Matching tolterodine placebo capsules.

Protocol document: