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临床试验/EUCTR2006-001716-71-FR
EUCTR2006-001716-71-FR进行中（未招募）1 期

A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS - HDL TURNOVER

sanofi aventis Groupe0 个研究点目标入组 80 人开始时间: 2006年12月29日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
80
研究概览入排标准研究者记录与标识符相似试验

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 must be obtained in writing for all patients at enrollment into the study
  • •2)Male or female 35-65 years of age
  • •3)Females must be post-menopausal (menopause is defined as 6 months of amenorrhea and plasma FSH > 20 U/L)
  • •4)BMI > 27 kg/m² and < 40 kg/m²
  • •5)Willingness and ability to comply with the study protocol
  • •6)Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men.
  • •7)With at least one lipid abnormality defined as:
  • •- Fasting Triglycerides level >1.7 mmol/L (150 mg/dL) and < 4.5 mmol/L (400 mg/dL)
  • •- HDL < 1.03 mmol/L (40 mg/dL) in men and < 1.29 mmol/L (50 mg/dL) in women
  • •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) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1) HDL< or = 0.60 mmol/L (23 mg/dl)
  • •2)Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
  • •3)Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
  • •4)Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
  • •5)ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
  • •6)Type 2 diabetes treated with oral agents and/or insulin
  • •7)Diet treated type 2 diabetic patients with HbA1c = 7%
  • •8)History of cardio vascular disease (myocardial infarction, angina, stroke, confirmed peripheral arterial disease, coronary and peripheral vascular Surgery (CABG, PCI…)
  • •9)Systolic blood pressure = 160 mm Hg or diastolic blood pressure = 95 mm Hg
  • •10)Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
  • •11)Body weight fluctuation > 5 Kg during the previous 3 months
  • •12)History of bulimia or anorexia nervosa by DSM-IV criteria
  • •13)Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder
  • •14)Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status)
  • •15)Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the patient must not be included in the study
  • •16)Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
  • •17)Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study:
  • •Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
  • •Any history of cardiac failure
  • •Relevant acute abnormal finding seen on ECG
  • •Significant haematology abnormalities (haemoglobin < 120 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L)
  • •18)Patient treated for epilepsy
  • •19)Uncontrolled serious psychiatric illness such as a major depression
  • •20)History of alcohol and/or drug abuse
  • •21)Smoker or smoking cessation within the past 3 months
  • •22)Marijuana or hashish users
  • •23)Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
  • •24)Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
  • •25)Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
  • •26)History of peptic ulcer
  • •27)Willebrand disease or other hemorrhagic diatheses
  • •Concomitant medications prior and during the study:
  • •28)Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
  • •-Lipid-lowering drugs intake (statin, fibrate, bile acid sequestrant, ezetimibe, nicotinic acid)
  • •-Other drugs for weight reduction (phentermine, amphetamines)

研究者

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