EUCTR2008-007087-42-HU进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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