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Clinical Trials/NCT01901120
NCT01901120
Completed
Not Applicable

Long-Term Specified Drug Use-results Survey of Betanis Tablets

Astellas Pharma Inc0 sites1,263 target enrollmentStarted: October 2012Last updated:
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ConditionsOveractive Bladder
InterventionsBetanis
DrugsBetanis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1,263
Primary Endpoint
Occurrence of adverse events
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Betanis

the usual adult dosage of mirabegron once daily after a meal

Intervention: Betanis (Drug)

Outcomes

Primary Outcomes

Occurrence of adverse events

Time Frame: Up to 36 months after treatment

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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