EUCTR2010-020601-32-IT进行中（未招募）不适用
A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder - ND
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
- 1,658
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 at Visit 1/Screening
- •1.Subject is male or female and at least 18 years of age;
- •2.Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m2 and a total body weight between 50 and 95
- •3.Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent
- •and privacy language as per national regulations has been obtained from the subject prior to any study-related
- •procedures (including discontinuation of prohibited medication, if applicable);
- •4. Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing 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
- •5. Subject has symptoms of OAB (urinary frequency, urgency and/or urgency incontinence) for at least 3 months
- •Inclusion Criteria at Visit 2/Placebo Run-In
- •6. Subject must still fulfill all inclusion criteria and none of the exclusion criteria for Visit 1;
- •7. Subject is willing and able to complete the micturition diary correctly and is willing 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
- •Inclusion Criteria at Visit 3/Baseline
- •8. Subject continues to meet all inclusion criteria and none of the exclusion criteria for Visit 1;
- •9. Subject has experienced frequency of micturition on average = 8 times per 24-hour period during the 3-day
- •micturition diary period (incontinence episode should not be counted as a micturition);
- •10. Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without
- •urgency incontinence) during the 3 day micturition diary period.
- •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
- •Exclusion Criteria at Visit 1/Screening
- •1. Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (ß-HCG
- •in serum) at Screening must be negative in women of childbearing potential;
- •2. Female subjects of childbearing potential and not using a highly effective method of birth control during the
- •study and for 30 days after final study drug administration.
- •3. Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not
- •using a barrier method of contraception during the study and for 30 days after final study drug administration. In
- •addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly
- •effective method of birth control during the study and for 30 days after final study drug administration. Highly
- •effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate
- •(i.e. less than 1% per year) when used consistently and correctly.
- •4. In the opinion of the Investigator, the subject has clinically significant bladder outflow obstruction at risk of
- •urinary retention;
- •5. Subject has significant PVR volume (> 150 mL);
- •6. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the
- •predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation
- •7. Subject has a neurological cause for detrusor overactivity;
- •8. Subject has an indwelling catheter or practices intermittent self-catheterization;
- •9. Subject has diabetic neuropathy;
- •10. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy
- •or previous or current malignant disease of the pelvic organs;
- •11. Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
- •12. Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin,
- •13. Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis
- •or Crohn’s Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of
- •anticholinergics contraindicated;
- •14. Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to
- •Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure
- •and stroke;
- •15. Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a
- •bladder training program or pelvic floor exercises which started more than 30 days prior to Screening);
- •16. Subject is using medications intended to treat OAB or prohibited medications. Subject is excluded if using
- •restricted medications under conditions different to those specified in the Concomitant Medication” section;
- •17. Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their
- •excipients;
- •18. Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder,
- •systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson’s disease);
- •19. Subject has severe hypertension which is defined as a sitting average systolic blood pressure = 180 mmHg
- •and/or an average diastolic blood pressure = 110 mmHg;
研究者
相似试验
进行中（未招募）
不适用
A study in patients with overactive bladder to evaluate the efficacy, safety and tolerability of a combination of two drugs (solifenacin succinate and mirabegron) with either drug alone, and to find the best dose for each of the drugs in combinatioOveractive BladderMedDRA version: 14.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-020601-32-FIAstellas Pharma Europe BV1,658
进行中（未招募）
不适用
A study in patients with overactive bladder to evaluate the efficacy, safety and tolerability of a combination of two drugs (solifenacin succinate and mirabegron) with either drug alone, and to find the best dose for each of the drugs in combinatioOveractive BladderMedDRA version: 14.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-020601-32-CZAstellas Pharma Europe BV1,658
进行中（未招募）
不适用
A study in patients with overactive bladder to evaluate the efficacy, safety and tolerability of a combination of two drugs (solifenacin succinate and mirabegron) with either drug alone, and to find the best dose for each of the drugs in combinatioMedDRA version: 14.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersOveractive BladderEUCTR2010-020601-32-DEAstellas Pharma Europe BV1,658
进行中（未招募）
不适用
A study in patients with overactive bladder to evaluate the efficacy, safety and tolerability of a combination of two drugs (solifenacin succinate and mirabegron) with either drug alone, and to find the best dose for each of the drugs in combinatioMedDRA version: 14.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersOveractive BladderEUCTR2010-020601-32-DKAstellas Pharma Europe BV1,658
进行中（未招募）
不适用
A study in patients with overactive bladder to evaluate the efficacy, safety and tolerability of a combination of two drugs (solifenacin succinate and mirabegron) with either drug alone, and to find the best dose for each of the drugs in combinatioMedDRA version: 13.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 10038359 - Renal and urinary disordersOveractive BladderEUCTR2010-020601-32-HUAstellas Pharma Europe BV1,658