NCT00396448终止3 期
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1,253
- 试验地点
- 1
- 主要终点
- Change in body weight and proportion of subjects with 5% weight loss
研究概览
简要总结
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
详细描述
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
排除标准
- •Pregnancy
- •Adults with serious or unstable current or past medical conditions
研究组 & 干预措施
CP-945,598 Treatment B
Experimental
干预措施: CP-945,598 Treatment B (Drug)
CP-945,598 Treatment A
Experimental
干预措施: CP-945,598 Treatment A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in body weight and proportion of subjects with 5% weight loss
时间窗: 1 year
次要结局
- Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK(1-2 years)
研究者
研究点 (1)
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