Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.
详细描述
The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female: postmenopausal OAB outpatient
- •Male: OAB outpatient who did not wish to have children at all
- •Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
- •Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points
排除标准
- •Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
- •Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
- •Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period
研究组 & 干预措施
Concomitant Group
concomitant administration of mirabegron to solifenacin treated patients
干预措施: mirabegron (Drug)
Concomitant Group
concomitant administration of mirabegron to solifenacin treated patients
干预措施: solifenacin (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug up to weeks 16
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.
次要结局
- Change From Baseline in OABSS Total Score(Baseline and week 8, 16)
- Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score(Baseline and week 8, 16)
- Change From Baseline in OAB-q SF Total HRQL Score(Baseline and week 8, 16)
- Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours(Week 16)
- Change From Baseline in the Number of Nocturia Episodes Per Night(Baseline and week 4, 8, 12, 16)
- Change From Baseline in Postvoid Residual (PVR) Volume(Baseline and week 4, 8, 12, 16)
- Number of Participants Who Achieved Normalization for OABSS Total Score(Week 8 and 16)
- Change From Baseline in the Number of Urgency Episodes Per 24 Hours(Baseline and week 4, 8, 12, 16)
- Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours(Week 16)
- Change From Baseline in the Number of Incontinence Episodes Per 24 Hours(Baseline and week 4, 8, 12, 16)
- Change From Baseline in the Number of Micturitions Per 24 Hours(Baseline and week 4, 8, 12, 16)
- Change From Baseline in the Volume Voided Per Micturition(Baseline and week 8, 16)
- Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours(Week 16)
- Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours(Baseline and week 4, 8, 12, 16)