A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,400
- 主要终点
- Decreases body weight; safety and tolerability
研究概览
简要总结
A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.
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
- •Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea
排除标准
- •Patients with serious or unstable current or past medical conditions
研究组 & 干预措施
Phase A/B: Arm 2
Phase A: Arm 2: MK0364 2 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.
干预措施: taranabant (Drug)
Phase A/B: Arm 3
Phase A: Arm 3: MK0364 4 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3:
MK0364 4 mg capsule once daily.
干预措施: taranabant (Drug)
Phase A/B: Arm 4
Phase A: Arm 4: MK0364 6 mg capsule once daily.
Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4:
MK0364 6 mg capsule once daily.
干预措施: taranabant (Drug)
Phase A/B: Arm 5
Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.
干预措施: taranabant (Drug)
结局指标
主要结局
Decreases body weight; safety and tolerability
时间窗: 156 Weeks
次要结局
- Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity(156 Weeks)