NCT00408148终止3 期
A Randomized, Double-blind, Two Arm, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The fractional catabolic rate (FCR) of HDL ApoA-I
研究概览
简要总结
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.
Primary objectives:
- To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).
Secondary objectives:
- To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
- To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
- To assess effect of Rimonabant on body composition
- To assess safety of Rimonabant
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominally obese patients with additional cardiometabolic risk factors
- •Females must be post-menopausal
- •BMI > 27 kg/m² and < 40 kg/m²
- •Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men
- •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
排除标准
- •HDL ≤ 0.60 mmol/L (23 mg/dl)
- •Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
- •Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
- •Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- •ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
- •Type 2 diabetes treated with oral agents and/or insulin
- •Diet treated type 2 diabetic patients with HbA1c ≥ 7%
- •History of cardio vascular disease
- •Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg.
- •Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
- •Body weight fluctuation > 5 Kg during the previous 3 months
- •History of bulimia or anorexia nervosa by DSM-IV criteria
- •Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder.
- •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.)
- •Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening.
- •Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
- •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
- •Patient treated for epilepsy
- •Ongoing major depressive illness
- •Uncontrolled psychiatric illness
- •History of alcohol and/or drug abuse
- •Smoker or smoking cessation within the past 3 months
- •Marijuana or hashish users
- •Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
- •Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
- •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
- •Recent history of active peptic ulcer
- •Willebrand disease or other hemorrhagic diatheses
- •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
- •Anti obesity drugs
- •Other drugs for weight reduction (phentermine, amphetamines)
- •Herbal preparations for weight reduction
- •Other drugs known to affect lipid metabolism: retinoids, antiretroviral, estrogens and hormone replacement therapy, cyclosporine, glitazones, benfluorex, fish oils, plant sterols.
- •Thiazids (including fixed combination) at daily dose higher than 12.5 mg
- •Unselective beta-blockers
- •Prolonged use (more than one week) of systemic corticosteroids, neuroleptics
- •Anticoagulants
- •Ongoing antidepressive treatment
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
2
Placebo Comparator
Administration of one rimonabant placebo tablet once daily in the morning
干预措施: Placebo (Drug)
1
Experimental
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
干预措施: Rimonabant (Drug)
结局指标
主要结局
The fractional catabolic rate (FCR) of HDL ApoA-I
时间窗: After 12 months of treatment.
次要结局
- Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II(All across the study)
- PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B(All across the study)
- Variation in ApoA-I, ApoA-II, Lp-AI, Lp-AII, pre-beta-HDL HDL2a, HDL2b, HDL3a, HDL3b, HDL3c, Apo B, Apo C III, TG, LDL-C, HDL-C levels(All across the study)
- Variation in Glucose, insulin, HbA1c, leptin, adiponectin(All across the study)
- Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma(All across the study)
- Variation in whole body fat(All across the study)
- Variation in abdominal sub-cutaneous and visceral fat(All across the study)
- Variation in liver fat(All across the study)
- Variation in blood pressure(All across the study)
- Variation in body weight, waist circumference, waist/hip ratio(From the beginning to the end of the study)
- CE/TG ratio in HDL(All across the study)
- Adverse events(From the beginning to the end of the study)
研究者
研究点 (1)
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