MedTrace Logo

Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

NCT03044912 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2017-02-09

No results posted yet for this study

Summary

Recent phase III trials have confirmed the efficacy and safety of mirabegron in the treatment of overactive bladder (OAB) in Europeans, Australians, North Americans, Japanese and Asians. Whether mirabegron 25mg or 50mg should be used as the first line treatment for OAB has not been determined yet. The dose effectiveness relationship between 25mg and 50mg mirabegron has also not been investigated yet. Hence, investigators have conducted this post marketing study in order to evaluate the efficacy and safety between mirabegron 25mg and 50mg in Taiwanese people with symptoms of OAB.

Conditions

  • Overactive Bladder Syndrome

Interventions

DRUG

mirabegron

To evaluate the efficacy and safety of Mirabegron 50 mg vs 25 mg in Taiwanese patients with overactive bladder syndrome

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Hann-Chorng Kuo, M.D. · Buddhist Tzu Chi General Hospital, Hualien, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-16
Primary Completion
2019-02-01
Completion
2019-08-01
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044912 on ClinicalTrials.gov