NCT00384605终止3 期
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,000
- 主要终点
- Body weight after 52 weeks of treatment
研究概览
简要总结
A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
- •Stable weight (+/-3 kg) for at least 3 months prior to study start
排除标准
- •History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
- •Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg
研究组 & 干预措施
1
Experimental
Arm 1: MK0364 2 mg capsule once daily
干预措施: taranabant (Drug)
2
Experimental
Arm 2: MK0364 1 mg capsule once daily
干预措施: taranabant (Drug)
3
Experimental
Arm 3: MK0364 0.5 mg capsule once daily.
干预措施: taranabant (Drug)
4
Placebo Comparator
Arm 4: Pbo capsule once daily.
干预措施: placebo (Drug)
结局指标
主要结局
Body weight after 52 weeks of treatment
时间窗: 52 weeks
次要结局
- Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment(52 weeks)
研究者
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