A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Summary
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
Timeline
- Start
- 2009-04-28
- Primary completion
- 2010-04-27
- Completion
- 2010-04-27
Outcome
Met primary endpoint
paper Both mirabegron groups demonstrated statistically significant improvements in coprimary endpoints vs placebo. PMID 23769122 ↗
registry Placebo vs Mirabegron 25 mg; p = 0.005; LS Mean Difference -0.40 (95% CI -0.74 to -0.06) NCT00912964 ↗
registry Placebo vs Mirabegron 50 mg; p = 0.001; LS Mean Difference -0.42 (95% CI -0.76 to -0.08) NCT00912964 ↗
registry Placebo vs Mirabegron 25 mg; p = 0.007; LS Mean Difference -0.47 (95% CI -0.82 to -0.13) NCT00912964 ↗
registry Placebo vs Mirabegron 50 mg; p = 0.015; LS Mean Difference -0.42 (95% CI -0.76 to -0.08) NCT00912964 ↗
Publications
- Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.
- Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 25 mg | Oral |
| Subject | Mirabegron | Other / unclassified | 50 mg | Oral |