Clinical Trials Logo
  1. Home
  2. Urge Incontinence
  3. NCT04562090

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

Urge Incontinence Clinical Trial

Official title:
A Phase 4, Open-label, Randomized, Prospective, Interventional Post-authorization Efficacy and Safety Study of Mirabegron 50 mg and 25 mg for the Treatment of Overactive Bladder in Chinese Subjects

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy of mirabegron for the treatment of overactive bladder (OAB) in Chinese participants. This study also evaluated the safety of mirabegron for the treatment of OAB in Chinese participants, evaluated other efficacy variables of mirabegron for the treatment of OAB and explored different mirabegron starting doses.

Clinical Trial Description

The study followed an open-label, randomized, 12-week, prospective, interventional post-authorization design for the treatment of OAB in 249 Chinese participants. Each eligible participant took part in a 12-week treatment period. Treatments were administered once daily orally after a meal during a 12-week, open-label treatment period. Study visits took place at weeks 4, 8 and 12. For the 25 mg mirabegron group, a dose escalation to 50 mg was permitted on visit 3 and visit 4 at the investigators' discretion. 15 study sites across China enrolled participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04562090
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 4
Start date January 6, 2021
Completion date March 30, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Active, not recruiting NCT04936464 - Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence N/A
Completed NCT04470765 - Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Recruiting NCT05099419 - Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence Early Phase 1
Recruiting NCT05874375 - UCon Treatment of Overactive Bladder (OAB) in Males N/A
Active, not recruiting NCT05241379 - AURA-2: Augmenting Urinary Reflex Activity N/A
Completed NCT02657057 - Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB N/A
Withdrawn NCT00773552 - Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder Phase 4
Recruiting NCT04752709 - Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women N/A
Recruiting NCT03755089 - Oral vs Intravesical Analgesia for Office Bladder Botox Injections Phase 4
Terminated NCT03687164 - Group Medical Visits for Latina Women With Urgency Urinary Incontinence N/A
Withdrawn NCT03697954 - Direct Full-stage Implantation of Sacral Neuromodulation
Completed NCT00337558 - A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) Phase 4
Completed NCT03180372 - Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence N/A
Recruiting NCT05783219 - Lidocaine Patches Prior to Percutaneous Nerve Evaluation Phase 2
Active, not recruiting NCT05308979 - Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial Phase 4
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT01391780 - Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence N/A
Completed NCT03655054 - eCoin for OAB Feasibility Follow-on Study N/A