EUCTR2008-001049-24-ES进行中（未招募）不适用
Efecto de liraglutida en el peso corporal en sujetos no diabéticos obesos o con sobrepeso y comorbilidad.Ensayo clínico aleatorizado, doble-ciego, controlado con placebo, grupos paralelos, multicéntrico, multinacional, con estratificación de sujetos a uno o tres años de tratamiento basada en el estatus pre-diabético en la aleatorización
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,800
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. Informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
- •2. Body Mass Index (BMI) = 30.0 kg/m^2 or = 27 kg/m^2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia according to ATP-III)
- •3. Stable body weight (less than 5 kg self-reported change during the previous 3 months)
- •4. Preceding failed dietary effort
- •5. Age = 18 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:
- •Known type 1 or type 2 diabetes
- •HbA_1c = 7 % or FPG = 7 mmol/L
- •History of acute or chronic pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
- •Uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg)
研究者
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