A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 14,673
- 试验地点
- 478
- 主要终点
- Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.
详细描述
Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1, stratified by the presence of established CV disease (approximately 80%) or CV risk factors without established CV disease (approximately 20%). Subjects will receive lorcaserin HCl 10 mg BID or placebo BID. The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will last up to 30 days and consist of one visit during which subjects will be screened for eligibility. The Randomization Phase will consist of two periods: Treatment and Follow-up. The Treatment Period will last for approximately 5 years with approximately 18 visits and Follow-up period is 30 (+ or - 10 days) from the end of treatment visit.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lorcaserin hydrochloride (HCL)10 mg
APD356 10 mg twice daily
干预措施: Lorcaserin hydrochloride (Drug)
Placebo
Placebo twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis
时间窗: Baseline up to Month 42
The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
Time From Randomization to First Occurrence of MACE+
时间窗: Baseline up to end of study (Month 56)
The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.
次要结局
- Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline(Baseline up to end of study (Month 56))
- Time From Randomization to First Occurrence of the Individual Components of MACE+(Baseline up to end of study (Month 56))
- Time From Randomization to Event of All-cause Mortality(Baseline up to end of study (Month 56))
- Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline(Baseline up to end of study (Month 56))
- Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline(Baseline up to end of study (Month 56))
- Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline(Baseline, and Month 6)
- Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants(Baseline up to end of study (Month 56))
- Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline(Baseline up to end of study (Month 56))
- Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy(Months 6 and 12)
- Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline(Baseline up to end of study (Month 56))
- Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure(Baseline, Month 12)
- Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline(Baseline up to end of study (Month 56))
- Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes(Months 6 and 12)