Symptoms of Overactive Bladder MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: Mirabegron OCAS tablet 50 mg
Product Code: YM178
Pharmaceutical Form: Modified-release tablet
CAS Number: 223673-61-8
Current Sponsor code: YM178
Concentration unit: mg milligram(s)
Conc
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at Visit 1/screening 1. Male or female subject aged = 18 years. 2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations is obtained from the subject or legally authorized representative (prior to any study-related procedures; including withdrawal of prohibited medication, if applicable). 3. Subject is willing and able to complete the micturition diary and questionnaires correctly. 4. Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for = 3 months. Inclusion criteria at Visit 2/baseline 5. Subject experiences frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period. 6. Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period. 7. Subject still fulfills all inclusion criteria and none of the exclusion criteria from Visit 1. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria at Visit 1/screening 1. Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of 3000 mL as recorded in the 3-day micturition diary period. 16. Subject has - in the opinion of the investigator - clinically significant increases in laboratory values as assessed in Visit 1 samples (e.g. serum creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal range (ULN), or ?-GT > 3x ULN). 17. Subject has severe hypertension, which is defined as a sitting average systolic blood pressure=180 mmHg and /or average diastolic blood pressure = 110 mmHg (see section 5.4.1 Vital Signs). 18. Subject has an abnormal ECG, which in the opinion of the investigator makes the subject uns
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of YM178 50 mg qd and YM178 100 mg qd against placebo in the treatment of subjects with symptoms of overactive bladder.;Secondary Objective: To assess the safety and the tolerability of YM178 50 mg qd and YM178 100 mg qd against placebo in the treatment of subjects with symptoms of overactive bladder. To compare the efficacy and safety of YM178 with tolterodine SR 4 mg qd in the treatment of subjects with symptoms of overactive bladder.;Primary end point(s): Change from baseline to end of treatment in mean number of micturitions/24 h based on a 3-day micturition diary Change from baseline to end of treatment in mean number of incontinence episodes/24h based on a 3-day micturition diary | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed