NCT00325546已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20mg), Multi-National, Multicentre Study of Weight-Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 643
- 试验地点
- 4
- 主要终点
- Absolute change in weight from baseline to month 9
研究概览
简要总结
Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients.
Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability
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)> 25 kg/m²
排除标准
- •Absence of stable weight (variation < 5 kg) within three months prior to screening visit),
- •Absence of effective contraceptive method for females of childbearing potential,
- •Presence of treated or untreated type 1 or type 2 diabetes,
- •Systolic blood pressure > 165 mm Hg and/or diastolic blood pressure > 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit,
- •Presence of secondary hypertension,
- •Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...)
- •Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study,
- •Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit.
- •Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
- •Related to previous or concomitant medications :
- •Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
- •Antidiabetic drugs.
- •Related to laboratory findings:
- •Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
- •Abnormal TSH level (TSH > ULN or < LLN).
- •Positive urine pregnancy test.
结局指标
主要结局
Absolute change in weight from baseline to month 9
次要结局
- HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
研究者
研究点 (4)
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