Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 18,695
- 试验地点
- 2
- 主要终点
- First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
研究概览
简要总结
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.
The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
详细描述
The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.
- •CHD equivalents:
- •Recent (within 3 years)documented heart attack
- •Documented symptomatic coronary artery disease
- •Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
- •Documented symptomatic peripheral arterial disease
- •Major risk factors:
- •Documented type 2 diabetes mellitus
- •Metabolic syndrome (NCEP criteria)
- •Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
- •Elevated high-sensitivity C-reactive protein
- •Age > or = 65 years for males, age > or = 70 years for females
排除标准
- •Obesity of known endocrine origin
- •Pregnant or breastfeeding women
- •Very low calorie diet or weight loss surgery within past 6 months
- •Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
- •Likely cardiovascular intervention within next 1 month
- •Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
- •Receipt of investigational product within past 30 days
研究组 & 干预措施
Rimonabant
Rimonabant 20 mg once daily
干预措施: Rimonabant (Drug)
Placebo
Placebo (for Rimonabant) once daily.
干预措施: Placebo (for Rimonabant) (Drug)
结局指标
主要结局
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
时间窗: From randomization up to common study end date (33-50 months)
次要结局
- First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization(From randomization up to common study end date (33-50 months))
- All-cause mortality(From randomization up to common study end date (33-50 months))