Overactive Bladder MedDRA version: 17.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To evaluate Patient Reported Outcomes (PRO) during long-term combination treatment with solifenacin and mirabegron ;Primary end point(s): • Incidence and severity of treatment emergent adverse events (TEAEs) Primary Efficacy Variables • Change from baseline in mean number of incontinence episodes per 24 hours at EoT • Change from baseline in mean number of micturitions per 24 hours at EoT;Timepoint(s) of evaluation of this end point: EoT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Vital signs • Laboratory test • ECG parameters • PVR ;Timepoint(s) of evaluation of this end point: EoT | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactService Desk - Gobal Clinical Dev't
Astellas Pharma Europe B.V.
Outcome results
None listed