Symptoms of overactive bladder
Conditions
Interventions
Product Name: YM178 OCAS tablet 25 mg
Product Code: YM178
Pharmaceutical Form: Modified-release tablet
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the place
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subject is eligible for the study if all of the following apply: Inclusion Criteria at Visit 1/Screening 1. Male or female subject = 18 years of age. 2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) 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 incontinence) for = 3 months. Inclusion Criteria at Visit 2/Baseline 5. Subject must experience 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 must still fulfill all inclusion criteria and none of the exclusion criteria of 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: 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. 14. Subject has serum creatinine >150 µmol/L or AST or ALT > 2x upper limit of normal range (ULN), or ?-GT > 3x ULN as assessed in Visit 1 samples and considered clinically significant by the investigator. 15. 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). 16. Subject has an abnormal ECG, which in the opinion of the investigator makes the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of YM178 25 mg qd and YM178 50 mg qd against placebo in the treatment of subjects with symptoms of overactive bladder.;Secondary Objective: To assess the safety and tolerability of YM178 25 mg qd and YM178 50 mg qd against placebo in the treatment of subjects with symptoms of overactive bladder.;Primary end point(s): Co-primary efficacy variables: • Change from baseline in mean number of micturitions/24 h based on a 3-day micturition diary, • Change from baseline in mean number of incontinence episodes/24 h based on a 3-day micturition diary. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Hungary, Portugal, Spain, Sweden
Outcome results
None listed