Main
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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:
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EUCTR |
Last refreshed on:
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27 May 2013 |
Main ID: |
EUCTR2011-005713-37-LV |
Date of registration:
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14/05/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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:
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06/07/2012 |
Target sample size:
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1992 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005713-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Armenia
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Australia
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Austria
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Belarus
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Denmark
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Egypt
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Finland
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Georgia
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Jordan
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Kazakhstan
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Latvia
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Lebanon
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Lithuania
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Netherlands
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Norway
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Poland
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Portugal
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Russian Federation
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Slovenia
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Spain
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Sweden
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Switzerland
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Turkey
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Ukraine
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United Kingdom
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Contacts
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Name:
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Service Desk
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Address:
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Elisabethhof 19
2353 EW
Leiderdorp
Netherlands |
Telephone:
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00310715455878 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Global Development Operations |
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Name:
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Service Desk
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Address:
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Elisabethhof 19
2353 EW
Leiderdorp
Netherlands |
Telephone:
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00310715455878 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Global Development Operations |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Overactive bladder MedDRA version: 14.1
Level: LLT
Classification code 10059617
Term: Overactive bladder
System Organ Class: 10038359 - Renal and urinary disorders
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Therapeutic area: Body processes [G] - Physical Phenomena [G01]
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Intervention(s)
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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 unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Prolonged-release film-coated 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
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Day 1, Week 4, Week 8, Week 12
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Primary end point(s): Change from baseline in the mean number of micturitions per 24 hours, based on a 3-day micturition diary.
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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.
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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.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Day 1 - week 12
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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.
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Secondary ID(s)
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2011-005713-37-IE
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178-EC-001
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Source(s) of Monetary Support
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Astellas Pharma Europe Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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