EUCTR2012-005735-91-ES进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,500
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 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 or systemic or central neurological disease such as multiple sclerosis and Parkinson?s disease).
- •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 a QTcF interval > 450 ms for males or > 470 ms for females 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
相似试验
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Subjects with Major Depressive DisorderMedDRA version: 18.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873Major Depressive DisorderEUCTR2015-000306-18-FIMinerva Neurosciences, Inc.80
未知
3 期
A Phase III Study of SM-13496 in Patients with Bipolar I Depression.JPRN-jRCT2080222269Sumitomo Dainippon Pharma Co., Ltd.501
进行中（未招募）
不适用
This is a multinational study comparing the efficacy and safety of two medicines , solifenacin succinate and mirabegron taken together, or separately, or a mock treatment (placebo) in subjects with symptoms of overactive bladder.MedDRA version: 17.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857Overactive BladderEUCTR2012-005735-91-EEAstellas Pharma Europe B.V.7,000
已完成
Unknown
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Plant-based extract mixture on Hangover ImprovementMental and behavioural disordersKCT0008402H Plus Yangji Hospital80
进行中（未招募）
不适用
This is a multinational study comparing the efficacy and safety of two medicines , solifenacin succinate and mirabegron taken together, or separately, or a mock treatment (placebo) in subjects with symptoms of overactive bladder.Overactive BladderEUCTR2012-005735-91-LVAstellas Pharma Europe B.V.4,500