EUCTR2010-020601-32-FI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. - Symphony
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 kg;
- •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 1045
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 613
排除标准
- •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.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.
- •3.Subject has significant PVR volume (> 150 mL);
- •4.Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator 6.Subject has a neurological cause for detrusor overactivity;
- •5.Subject has an indwelling catheter or practices intermittent self-catheterization;
- •6.Subject has diabetic neuropathy;
- •7.Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
- •8.Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
- •9.Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
- •10.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;
- •11.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;
- •12.Subject is receiving current non-drug treatment including electro-stimulation therapy 15.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;
- •13.Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients;
- •14.Subject has any significant neurological disease or defect affecting bladder function
- •15.Subject has severe hypertension 19.Subject has any clinically significant condition which in the opinion of the Investigator makes the subject unsuitable for the study;
- •16.Subject who participated in any clinical study or who has been treated with any investigational drug or device within 30 days (90 days in the UK) or the period stipulated by local regulations, whichever is longer, prior to Screening;
- •Exclusion Criteria at Visit 2/Placebo Run-In
- •17.Subject has evidence of a UTI (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re-screened if the initial screening visit (Visit 1b) was > 28 days;
- •18.Subject has a QT interval > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
- •19.Subject has clinically significant abnormalities on the 12-lead ECG;
- •20.Subject has serum creatinine > 150 µmol/L, AST and/or ALT > 2x upper limit of no
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