A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change in weight from baseline to 12 months
研究概览
简要总结
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.
Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass index (BMI) of at least 30 kg/m² or BMI >27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia
排除标准
- •Weight loss > 5 kg within 3 months prior to screening Visit.
- •Presence of any clinically significant endocrine disease including the presence of type 1 diabetes
- •Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- •Previous participation in a clinical study with rimonabant
- •Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction
- •Pregnancy and absence of effective contraceptive method for females of childbearing potential
- •Exenatide
- •Insulin therapy
- •Recent change or need for change in the oral antidiabetic treatment
- •Recent change or need for change in the lipid lowering treatment
- •Presence of severe renal or hepatic impairment
- •The above information is not intented to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
10 mg
干预措施: rimonabant (SR141716) (Drug)
2
20 mg
干预措施: rimonabant (SR141716) (Drug)
结局指标
主要结局
The primary endpoint is the change in weight from baseline to 12 months
时间窗: 12 months
次要结局
- Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline(12 months)
- Safety : Vital signs, adverse events, laboratory tests(12 months)