A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8,910
- 主要终点
- Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)
研究概览
简要总结
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years of age (women) or ≥45 years of age (men)
- •Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
- •Waist circumference ≥88 cm (women) or ≥102 cm (men)
- •At increased risk of adverse cardiovascular outcomes:
- •Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:
- •History of documented myocardial infarction >3 months prior to screening
- •History of coronary revascularization
- •History of carotid or peripheral revascularization
- •Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
- •Ankle brachial index <0.9 (by simple palpation) within prior 2 years
- •≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years
- •Type 2 diabetes mellitus with at least 2 of the following:
- •Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg)
- •Dyslipidemia requiring pharmacotherapy
- •Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within prior 12 months
- •Current tobacco smoker
排除标准
- •Myocardial infarction within 3 months prior to screening
- •Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
- •Clinical history of cerebrovascular disease (stroke)
- •History of tachyarrhythmia other than sinus tachycardia
- •Planned bariatric surgery, cardiac surgery, or coronary angioplasty
- •History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
- •History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
- •Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)
研究组 & 干预措施
NB32
干预措施: NB32 (Drug)
NB32
干预措施: Weight Management Program (Behavioral)
PBO
干预措施: PBO (Drug)
PBO
干预措施: Weight Management Program (Behavioral)
结局指标
主要结局
Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)
时间窗: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
次要结局
- Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization(Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)
- Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)(Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)
- Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)(Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)
- Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)(Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)