EUCTR2007-001452-39-IT进行中（未招募）不适用
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - taurus
Astellas Pharma B.V.0 个研究点目标入组 2,500 人开始时间: 2008年4月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
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
- •Subject is eligible for the study if all of the following apply:
- •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 with or without
- •incontinence (grade 3 or 4), during the 3-day micturition diary period.
- •7. Subject must still fulfill 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: 0
- •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
- •Subject will be excluded from participation if any of the following apply:
- •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 <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 (β-HCG in serum) at Visit 1
- •needs to be negative in women of childbearing potential.
- •2. Subject has clinically significant bladder outflow obstruction at risk of
- •urinary retention (at the discretion of the investigator).
- •3. 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 (Appendix 4)).
- •4. Subject has an indwelling catheter or practices intermittent selfcatheterization.5. Subject has diabetic neuropathy.
- •6. Subject has evidence of a symptomatic urinary tract infection, chronic
- •inflammation such as interstitial cystitis, bladder stones, previous pelvic
- •radiation therapy or previous or current malignant disease of the pelvic
- •7. Subject has uncontrolled narrow angle glaucoma, urinary or gastric
- •retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis or any
- •other medical condition which in the opinion of the investigator makes the
- •use of anticholinergics contraindicated.
- •8. 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).
- •9. Subject is using medications intended to treat OAB or prohibited
- •medications listed in Appendix 1 Part A. Subject is excluded if using
- •restricted medications (Appendix 1, Part B) and conditions specified in
- •Appendix 1, Part B are not met.
- •10. Subject has a known or suspected hypersensitivity to tolterodine, other
- •anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other
- •inactive ingredients.
- •11. Subject has any clinically significant condition, which in the opinion of the
- •investigator makes the subject unsuitable for the study.
- •12. Subject has been treated with any investigational drug within 30 days (90 in
- •the UK for all clinical studies except 178-CL-046) prior to Visit 1
- •/screening.
- •13. 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
- •14. Subject has an average total daily urine volume > 3000 mL as recorded in
- •the 3-day micturition diary period.
- •15. 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 γ-GT > 3x ULN)
- •16. Subject has an abnormal ECG, which in the opinion of the investigator
- •makes the subject unsuitable for the study.
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