NCT00420589终止3 期
A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients 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 at 52 weeks, safety and tolerability.
研究概览
简要总结
To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in 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
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
- •Patient is male or female >=18 and <= 65 years of age
- •Patient understands the study procedures and alternative treatments available
- •Patient is able to read, understand and complete study questionnaires
排除标准
- •Patient has a history or presence of a major psychiatric disorder
- •Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
- •Patient has a history of seizures or is at high risk of developing seizures
- •Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
- •Patient has diabetes mellitus as defined by medical history
研究组 & 干预措施
2
Experimental
Arm 2: MK0364 0.5 mg capsule once daily
干预措施: taranabant (Drug)
3
Experimental
Arm 3: MK0364 1 mg capsule once daily
干预措施: taranabant (Drug)
4
Experimental
Arm 4: MK0364 2 mg capsule once daily
干预措施: taranabant (Drug)
结局指标
主要结局
Body weight at 52 weeks, safety and tolerability.
时间窗: 52 weeks
次要结局
- Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.(52 weeks)
研究者
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