A trial comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin).

• Register: EUCTR
• Last refreshed on: 3 November 2014
• Main ID: EUCTR2012-005401-41-AT
• Date of registration: 01/07/2013
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe Ltd
• Public title: A trial comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin).
• Scientific title: A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms. - BESIDE
• Date of first enrolment: 08/08/2013
• Target sample size: 2170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005401-41
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Algeria, Armenia, Australia, Austria, Belgium, Canada, Denmark, Egypt, Finland, Georgia, Greece, Hungary, Ireland, Israel, Jordan, Kazakhstan, Korea, Republic of, Lebanon, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Service Desk
• Affiliation: Global Development Operations

• Name: Service Desk
• Affiliation: Global Development Operations

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has symptoms of OAB (urinary frequency [an average of at least 8 episodes per day] and urgency with urgency incontinence) for > 3 months prior to the screening visit
2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
3. Subject has symptoms of “wet” OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
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 1410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 760

Exclusion criteria:
1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
2. Subject has significant PVR volume (PVR > 150 ml).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
4. Subject has an indwelling catheter or practices intermittent self-catheterization.
5. Subject has evidence of a UTI.
6. Subject has 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
9. Subject has a clinically significant abnormal ECG
10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Overactive Bladder
MedDRA version: 16.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857

Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Intervention(s)

Trade Name: Betmiga
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
Other descriptive name: MIRABEGRON
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Trade Name: Betmiga
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
Other descriptive name: MIRABEGRON
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

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: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy

Timepoint(s) of evaluation of this end point: Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6).

Primary end point(s): Change from Baseline in mean number of incontinence episodes

Secondary Objective: - To evaluate the safety and tolerability of combination therapy versus solifenacin 5mg
and solifenacin 10mg monotherapy
- To evaluate the efficacy of combination therapy versus solifenacin 10mg monotherapy

Secondary Outcome(s)

Secondary end point(s): Change from Baseline in mean number of micturitions per 24 hours

Timepoint(s) of evaluation of this end point: Baseline Visit (Visit 3/Randomization) to end of Treatment (Visit 6).

Secondary ID(s)

2012-005401-41-GB

905-EC-012

Source(s) of Monetary Support

Astellas Pharma Europe Ltd