Status:
COMPLETED
A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
Lead Sponsor:
Astellas Pharma Europe Ltd.
Conditions:
Urinary Bladder Diseases
Urinary Bladder Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective ...
Eligibility Criteria
Inclusion
- Main Inclusion at Screening:
- Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for \>= 3 months prior to the screening visit
- 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;
- 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.
- Main Inclusion at Run-in (Visit 2):
- Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
- Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
- Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
- Main Inclusion at Randomization (Visit 3):
- Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.
Exclusion
- Main Exclusion at Screening:
- Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
- Subject has significant Post-void residual (PVR) volume (PVR \> 150 ml).
- Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
- Subject has an indwelling catheter or practices intermittent self catheterization.
- Subject has evidence of a UTI.
- Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
- Subject has moderate to severe hepatic impairment
- Subject has severe renal impairment or End Stage Renal disease
- Subject has a clinically significant abnormal Electrocardiogram (ECG)
- Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
- 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).
- Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
- 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.
- Main Exclusion at Randomization (visit 3):
- Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
- Subject does not desire an increase in study medication.
- Subject has an average total daily urine volume \> 3000ml as recorded in the micturition diary.
- 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.
- Subject has a clinically significant abnormal ECG
Key Trial Info
Start Date :
July 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2014
Estimated Enrollment :
2174 Patients enrolled
Trial Details
Trial ID
NCT01908829
Start Date
July 10 2013
End Date
November 25 2014
Last Update
October 31 2024
Active Locations (219)
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1
Genova Clinical Research
Tucson, Arizona, United States, 85704
2
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, United States, 90620
3
The American Institute of Research
Los Angeles, California, United States, 90017
4
Bayview Research Group
Valley Village, California, United States, 91607