Conditions: Urinary Bladder, Overactive
Keywords: Frequency Overactive Bladder Urgency Urinary urge incontinence Urinary incontinence Micturition
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2792
Healthy volunteers: no

Brief summary:
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

Detailed description:
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.

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

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

Protocol document: