EUCTR2012-005735-91-DE进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
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 male or female and at least 18 years of age;
- •Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
- •Subject has symptoms of wet” OAB (urinary frequency and urgency with incontinence) for at least 3 months;
- •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 3250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1250
排除标准
- •1. In the opinion of the investigator the subject has clinically significant bladder outflow obstruction at risk of urinary retention.
- •2. Subject has significant PVR volume (> 150 mL).
- •3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator.
- •4. Subject has a neurological cause for detrusor overactivity (e.g.
- •neurogenic bladder, diabetic neuropathy with autonomic component or
- •bladder involvement, or systemic or central neurological disease such as
- •multiple sclerosis and Parkinson's disease with autonomic component or
- •bladder involvement). An autonomic component can be inferred when
- •autonomic functions are affected, including heart rate, blood pressure,
- •perspiration and digestion.
- •5. Subject has an indwelling catheter or practices intermittent self-catheterization.
- •6. Subject has chronic inflammation such as bladder pain syndrome / interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
- •7. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
- •8. Subject has moderate to severe hepatic impairment
- •9. Subject has severe renal impairment
- •10. Subject has a clinically significant abnormal ECG
- •11. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
- •12. Subject has an average QTcF interval > 450 ms for males or > 470
- •ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome,
- •hypokalaemia).
- •13. Subject has severe hypertension, which is defined as a sitting average systolic blood pressure = 180 mmHg and/or average diastolic blood pressure = 110 mmHg.
研究者
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