Overactive Bladder MedDRA version: 16.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Interventions
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
Othe
Sponsors
Astellas Pharma Europe Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy;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;Primary end point(s): Change from Baseline in mean number of incontinence episodes ;Timepoint(s) of evaluation of this end point: Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Algeria, Armenia, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Egypt, Finland, Georgia, Greece, Hungary, Ireland, Israel, Jordan, Kazakhstan, Korea, Republic of, Lebanon, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactService Desk
Global Development Operations
Outcome results
None listed