A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (25 mg qd and 50 mg qd) in Subjects with Symptoms of Overactive Bladder - CAPRICOR
- Conditions
- Symptoms of overactive bladder
- Registration Number
- EUCTR2008-007087-42-FI
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1300
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
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 <1% per year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test (?-HCG in serum) at visit 1 needs to be negative in women of childbearing potential.
2. Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test).
3. Subject has an indwelling catheter or practices intermittent self-catheterization.
4. Subject has diabetic neuropathy.
5. Subject has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
6. Subject receives current non-drug treatment including electro-stimulation therapy (a bladder training program or pelvic floor exercises which started more than 30 days prior to entry into the study can be continued).
7. Subject is using medications intended to treat OAB or prohibited medications listed in Appendix 1, Part A of the protocol. Subject is excluded if using restricted medications (Appendix 1, Part B of the protocol) and the criteria specified in Appendix 1, Part B of the protocol are not met.
8. 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).
9. Subject has a known or suspected hypersensitivity to YM178, other ß3 agonists, or any of the inactive ingredients.
10. Subject has any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.
11. Subject has been part of any clinical study within 30 days (90 days in the UK) prior to Visit 1/screening, or has participated in any previous study with YM178.
12. Subject is an employee of the Astellas Group, third parties associated with the study, or the clinical study site team.
Exclusion criteria at Visit 2/Baseline
13. Subject had an average total daily urine volume > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method