NCT03583372已完成3 期
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 106
- 主要终点
- Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed participation in study RVT-901-
- •Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
排除标准
- •Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
- •Has coronary or neurovascular interventions planned during the duration of the study.
- •Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
- •Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute.
- •Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
- •Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-
- •Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-
- •Use of any prohibited medications as detailed in Section 7.7.
- •Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
- •Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
- •Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-
- •Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
- •Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
研究组 & 干预措施
Vibegron + Placebo to match Tolterodine
Experimental
干预措施: Vibegron (Drug)
Vibegron + Placebo to match Tolterodine
Experimental
干预措施: placebos (Drug)
Tolterodine + Placebo to match vibegron
Active Comparator
干预措施: placebos (Drug)
Tolterodine + Placebo to match vibegron
Active Comparator
干预措施: Tolterodine Tartrate ER (Drug)
结局指标
主要结局
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event
时间窗: up to 56 weeks
Adverse events were collected in participants with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
次要结局
- Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants(Baseline; Week 52)
- CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants(Baseline; Week 52)
- CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants(Baseline; Week 52)
- CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants(Baseline; Week 52)
研究者
研究点 (106)
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