jRCT2080224525已完成3 期
Semaglutide effects on cardiovascular outcomes in people with overweight or obesity (EX9536-4388) (SELECT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomised, double-blind, parallel group, multi-center
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 45age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female, age >= 45 years at the time of signing informed consent
- •Body mass index (BMI) >= 27 kg/m2
- •Have established CV disease as evidenced by at least one of the following:
- •prior myocardial infarctionprior stroke(ischemic or haemorrhagic stroke) orsymptomatic peripheral arterial disease(PAD),as evidenced by intermittent claudication with ankle-brachial index(ABI)<0.85 (at rest),orperipheral arterial revascularization procedure, or amputation due to atherosclerotic disease
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- •HbA1c >=48 mmol/mol (6.5 %) as measured by the central laboratory at screening
- •History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
结局指标
主要结局
-
efficacy Reduction of risk of Major adverse cardiovascular events.
次要结局
未报告次要终点
研究者
研究点 (1)
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SELECT - Semaglutide effects on heart disease and stroke in patients with overweight or obesityOverweightObesityMedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-003380-35-FIovo Nordisk A/S17,500