Randomized, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-media Thickness (CIMT), in Overweight Patients With Additional Risk Factors
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 661
- 试验地点
- 1
- 主要终点
- Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
研究概览
简要总结
Objectives:
- Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT)
- Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.
详细描述
This is a Phase III, prospective, multicentre, multinational, randomized, double-blind, placebo-controlled, 2-arm parallel group trial (rimonabant 20-mg od vs placebo). There will be a three-stage screening process including successively a Screening visit, a Screening CIMT and a validation of the Screening CIMT by the Imaging Core Laboratory. Patients complying with all inclusion and exclusion criteria will be randomized in one of the 2 treatment groups less than two weeks after Screening visit. Study drug (rimonabant 20 mg od or matching placebo) will be administered during 30 to 32 months. At inclusion, patients will be counseled to follow a mild hypocaloric diet, to increase their exercise level, and to stop smoking (if smokers). Glucose/lipid parameters will be assessed at Baseline and every 6 months until the Month 30 visit. CIMT will be performed at Baseline and every 6 months until final assessment at Month 30 (primary endpoint).A post-treatment follow-up visit at Month 35 will allow the collection of all adverse events and cardiovascular outcomes occurring after last study drug administration
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
- •Written and signed informed consent
- •Age greater than or equal to 55 years
- •Abdominal obesity defined by waist circumference > 88 cm (35 inches) in women and > 102 cm (40 inches) in men
- •Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:
- •Triglyceride level equal to or greater than 150 mg/dL
- •HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
- •Fasting glucose of equal to or greater than 110 mg/dL
- •High blood pressure defined as equal to or greater than 140 mmHg systolic and/or equal to or greater than 90 mmHg diastolic at screening visit or current treatment by antihypertensive medication.
- •Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement of greater than or equal to 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement less than 3 mm in any carotid artery segment.
- •All 6 carotid artery segments must have ultrasound images for all CIMT measurements
- •Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory's assessment.
排除标准
- •History of very low calorie diet or surgical procedures for weight loss within 6 months prior to screening visit
- •Obesity of known endocrine origin
- •Uncontrolled diabetes, i.e. with HbA1c > 10%
- •Anticipated survival less than 27 months
- •Presence of any severe medical or psychological condition, that in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
- •Presence of any other condition (e.g. geographic, social, or other), actual or anticipated, that the Investigator feels would restrict or limit the subject's participation for the duration of the study
- •Receipt of any investigational treatment (drug or device) within 30 days prior to Screening
- •Previous participation in a rimonabant study
- •Total occlusion of any carotid artery segment
- •Previous history of carotid intervention
- •Patient considered at high risk of carotid intervention during the next 27 months
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
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
时间窗: Month 30
次要结局
- First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)(From randomization to Month 35)
- First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death(From randomization to Month 35)