A randomized, double-blind, parallel-group, active-controlled, multi-center study to evaluate the long-term safety and efficacy of combination of solifenacin succinate with mirabegron compared to solifenacin succinate and mirabegron in subjects with overactive bladder
- Conditions
- -N31N31
- Registration Number
- PER-046-14
- Lead Sponsor
- Astellas Pharma Europe B.V,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 0
At Screening (Visit 1):
•Subject has completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion will no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 has been completed. In that case the subject has to be male or female and at least 18 years of age and the subject must have symptoms of wet” OAB (urinary frequency and urgency with incontinence) for at least 3 months.).
•Female subject must be either:
oOf non childbearing potential,
oOr, if of childbearing potential:
agree not to become pregnant during the study and for 28 days after the final study drug administration and
must have a negative urine pregnancy test at Screening and
if heterosexually active must use a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS.
• Male subject and their female spouse/partners who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS.
•Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings.
•Subject has a micturition frequency of on average at least 8 times per 24-hour period during the last 7 days of the micturition diary period.
•Subject has experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
•Subject has experienced on average at least 1 urgency episode (grade 3 or 4 on [PPIUS] scale) per 24-hour period during the 7-day micturition diary period.
•In the opinion of the investigator the subject has clinically significant bladder outflow obstruction at risk of urinary retention.
•Subject has significant PVR volume (> 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 a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy or systemic or central neurological disease such as multiple sclerosis and Parkinson’s disease).
•Subject has an indwelling catheter or practices intermittent self-catheterization.
•Subject has chronic inflammation such as bladder pain syndrome / interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
•Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
•Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn’s Disease, toxic megacolon, myasthenia gravis or any contraindications against the use of anticholinergics.
•Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months 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 clinically significant abnormal 12-lead ECG.
•Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.
•Subject has moderate to severe hepatic impairment. Subject has severe renal impairment.
•Subject has a current or previous malignant disease of the pelvis. Subjects with a history of (non-pelvic) cancer are considered eligible if the subject has undergone therapy and the subject has been considered disease free for at least 5 years.
• Subject is receiving current non-drug treatment for OAB including electrostimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening).
•Subject has evidence of a UTI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method