EUCTR2017-003380-35-IT进行中（未招募）1 期
SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity - SELECT
OVO NORDISK. S.P.A.0 个研究点目标入组 17,500 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, age equal to or above 45 years at the time of signing informed consent
- •2. Body mass index (BMI) equal to or above 27 kg/sqm
- •3. Have established CV disease as evidenced by at least one of the following:
- •- prior myocardial infarction
- •- prior stroke (ischemic or haemorrhagic stroke) or
- •- symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11375
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6125
排除标准
- •1. 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
- •2. HbA1c equal to or above 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
- •3. History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
研究者
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