drugset / Trial / NCT00662909
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder
Timeline
- Start
- 2008-03-28
- Primary completion
- 2009-04-22
- Completion
- 2009-04-22
Outcome
Met primary endpoint
registry Placebo vs Mirabegron 50 mg; p = 0.026; LS Mean Difference -0.34 (95% CI -0.66 to -0.03) NCT00662909 ↗
registry Placebo vs Mirabegron 100 mg; p <0.001; LS Mean Difference -0.50 (95% CI -0.82 to -0.18) NCT00662909 ↗
registry Placebo vs Mirabegron 50 mg; p = 0.001; LS Mean Difference -0.61 (95% CI -0.98 to -0.24) NCT00662909 ↗
registry Placebo vs Mirabegron 100 mg; p <0.001; LS Mean Difference -0.70 (95% CI -1.07 to -0.33) NCT00662909 ↗
Publications
- Background Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013 Apr;189(4):1388-95. doi: 10.1016/j.juro.2012.10.017. Epub 2012 Oct 16.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 50 mg | Oral |
| Subject | Mirabegron | Other / unclassified | 100 mg | Oral |