A study to assess the long-term efficacy and safety of two medicines, solifenacin succinate and mirabegron, taken together or separately, in patients with overactive bladder
- Conditions
- Overactive BladderTherapeutic area: Body processes [G] - Physical Phenomena [G01]MedDRA version: 17.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857
- Registration Number
- EUCTR2012-005736-29-GR
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1800
• Subject is male or female and at least 18 years of age;
• 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 symptoms of wet” OAB for at least three months
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 1728
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 672
• Subject has 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 chronic inflammation such as bladder pain syndrome /
interstitial cystitis, symptomatic bladder stones or any previous or
current radiation cystitis.
• Subject has moderate to severe hepatic impairment
• Subject has severe renal impairment
• Subject has a clinically significant abnormal 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 severe hypertension, which is defined as a sitting
average systolic blood pressure = 180 mmHg and/or average diastolic
blood pressure = 110 mmHg.
• 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 an indwelling catheter or practices intermittent self-catheterization;
• Subject has evidence of urinary tract infection (UTI), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
• Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of long-term combination treatment of solifenacin (5 mg) with mirabegron (50 mg) compared to solifenacin and mirabegron monotherapy in subjects with overactive bladder (OAB) ;Secondary Objective: To evaluate efficacy of long-term combination treatment with solifenacin and mirabegron<br><br>To evaluate Patient Reported Outcomes (PRO) during long-term combination treatment with solifenacin and mirabegron<br>;Primary end point(s): • Incidence and severity of treatment emergent adverse events (TEAEs)<br><br>Primary Efficacy Variables<br>• Change from baseline in mean number of incontinence episodes per 24 hours at EoT<br>• Change from baseline in mean number of micturitions per 24 hours at EoT;Timepoint(s) of evaluation of this end point: EoT
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Vital signs<br>• Laboratory test<br>• ECG parameters<br>• PVR<br>;Timepoint(s) of evaluation of this end point: EoT