Overview

This trial has been completed.

Condition overactive bladder
Treatment betanis
Sponsor Astellas Pharma Inc
Start date October 2012
End date September 2016
Trial size 1263 participants
Trial identifier NCT01901120, BE0002

Summary

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
the usual adult dosage of mirabegron once daily after a meal
betanis YM178
oral

Primary Outcomes

Measure
Occurrence of adverse events
time frame: Up to 36 months after treatment

Secondary Outcomes

Measure
Overactive Bladder Symptom Score (OABSS)
time frame: At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Additional Information

Official title Long-Term Specified Drug Use-results Survey of Betanis Tablets
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.