A study to evaluate the efficacy and safety of mirabegron compared to solifenacin in patients with overactive bladder who are previously treated with another medicine but were not satisfied with that treatment.

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy - BEYOND Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005713-37-IE

Enrollment

1992

Registered

2012-02-09

Start date

2012-04-05

Completion date

Unknown

Last updated

2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: mirabegron Product Code: YM178 Pharmaceutical Form: Prolonged-release film-coated tablet INN or Proposed INN: mirabegron CAS Number: 223673-61-8 Current Sponsor code: YM178 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for = 3 months prior to the Screening Visit. 2.Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. 3.The perception of the last treatment satisfaction on a 7 item Likert scale is extremely, very, or slightly dissatisfied. 4.Subject is willing and able to complete a micturition diary and questionnaires. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1394 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 598

Exclusion criteria

Exclusion criteria: 1.Subject has clinically significant Bladder Outlet Obstruction (BOO). 2.Subject has neurogenic bladder. 3.Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor. 4.Subject has an indwelling catheter or practices intermittent self-catheterization. 5.Subject has diabetic neuropathy. 6.Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs. 7.Subject has moderate to severe hepatic impairment. 8.Subject has severe renal impairment or End Stage Renal disease. 9.Subject has severe uncontrolled hypertension. 10.Subject’s last anti-muscarinic treatment was solifenacin.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Secondary Objective: To assess the safety and tolerability of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Primary end point(s): Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary.;Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 8, Week 12	—

Measure

Time frame

Main Objective: To assess the efficacy of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Secondary Objective: To assess the safety and tolerability of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.;Primary end point(s): Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary.;Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 8, Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of subjects reporting at least one treatment-emergent adverse event of dry mouth, constipation or blurred vision during double-blind treatment period. ;Timepoint(s) of evaluation of this end point: Day 1 - week 12	—

Countries

Armenia, Australia, Austria, Belarus, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Egypt, Finland, Georgia, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom

Contacts

Public ContactService Desk

Global Development Operations

contact@nl.astellas.com00310715455878

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026