A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

• Status: Completed
• Trial end date: 2013-07-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron; Solifenacin Succinate

Criteria

Inclusion Criteria:

• Female: postmenopausal OAB outpatient

• Male: OAB outpatient who did not wish to have children at all

• Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study

• Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points

Exclusion Criteria:

• Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction

• Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)

• Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period