Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 10,777
- 试验地点
- 1
- 主要终点
- Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
研究概览
简要总结
The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.
详细描述
The study consisted of 4 periods: 1) a Screening Period of approximately 2 weeks; 2) a 6-week Lead-in Period, during which subjects received single-blind sibutramine and country-specific standard of care for weight management. Subjects who discontinued study drug treatment during the Lead-in Period were not randomized and did not participate in the double-blind Treatment Period or the Follow-up Period; 3) a double-blind Treatment Period in which subjects were randomized to 1 of the 2 treatment groups and were followed until the study ended; and 4) a double-blind Follow-up Period, during which randomized subjects who discontinued study drug were followed until the study ended. The Randomization Phase consisted of the double-blind Treatment Period and the double-blind Follow-up Period. Subjects received country-specific standard of care for weight management during the Randomization Phase.
An independent events adjudication committee evaluated all potential cardiovascular outcome events and confirmed the outcome events and time of onset to be included in the statistical analyses.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's body mass index (BMI) was >= 27 kg/m(2) and <= 45 kg/m(2) or their BMI was >= 25 kg/m(2) and < 27 kg/m(2) with waist circumference of >= 102 cm in males or >= 88 cm in females.
- •Medical history positive for:
- •Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
- •Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)
排除标准
- •History of recent myocardial infarction.
- •Heart failure symptoms greater than New York Heart Association Functional Class II.
- •Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
- •Subjects without a pacemaker and with any of the following:
- •Sinus bradycardia (< 50 bpm)
- •Sick sinus syndrome
- •Atrioventricular block of more than 1st degree
- •Mean sitting systolic blood pressure (SBP) > 160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.
- •Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
- •Planned cardiac surgery or coronary angioplasty within 6 months of screening.
- •History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
- •Hyperthyroidism.
- •Known chronic liver disease or endstage renal disease.
- •Severe, symptomatic benign prostatic hyperplasia which may require surgery.
- •Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
- •Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
- •Treated hypertension stabilized for less than 3 months.
- •Inability to perform regular physical activity.
研究组 & 干预措施
Sibutramine
Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
干预措施: Sibutramine hydrochloride (Drug)
Placebo
Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
干预措施: Placebo (Drug)
Lead-in sibutramine
All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period
干预措施: Sibutramine hydrochloride (Drug)
结局指标
主要结局
Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
时间窗: From randomization up to 6 years
For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
次要结局
- Risk of Death From Any Cause (All-cause Mortality)(From randomization up to 6 years)
- Risk of Experiencing a POE or a Revascularization Procedure(From randomization up to 6 years)
- Risk of Experiencing a Nonfatal MI Included in the POE(From randomization up to 6 years)
- Risk of Experiencing a Nonfatal Stroke Included in the POE(From randomization up to 6 years)
- Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE(From randomization up to 6 years)
- Risk of Experiencing Cardiovascular Death Included in the POE(From randomization up to 6 years)