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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 20 May 2013
Main ID:  EUCTR2011-005713-37-NO
Date of registration: 26/04/2012
Prospective Registration: Yes
Primary sponsor: Astellas Pharma Europe Ltd
Public title: 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.
Scientific title: 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
Date of first enrolment: 02/07/2012
Target sample size: 1992
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005713-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Single-blind during the placebo run-in period If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
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
Name: Service Desk   
Address:  Sylviusweg 62 2300 AH Leiden Netherlands
Telephone: 00310715455878
Email: contact@nl.astellas.com
Affiliation:  Global Development Operations
Name: Service Desk   
Address:  Sylviusweg 62 2300 AH Leiden Netherlands
Telephone: 00310715455878
Email: contact@nl.astellas.com
Affiliation:  Global Development Operations
Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Overactive bladder
MedDRA version: 16.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Intervention(s)

Product Name: mirabegron
Product Code: YM178
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: mirabegron
CAS Number: 223673-61-8
Current Sponsor code: YM178
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Trade Name: Vesicare
Product Name: solifenacin succinate
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: solifenacin succinate
CAS Number: 242478-38-2
Current Sponsor code: YM905
Other descriptive name: SOLIFENACIN SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Primary end point(s): Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary.
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.
Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 8, Week 12
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Day 1 - week 12
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.
Secondary ID(s)
2011-005713-37-IE
178-EC-001
NCT01638000
Source(s) of Monetary Support
Astellas Pharma Europe Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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