NCT00483171终止3 期
A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In 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
- 699
- 试验地点
- 1
- 主要终点
- Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
研究概览
简要总结
The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
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
- •Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities; >/=27 kg/m2 for subjects with co morbidities
- •Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.
排除标准
- •Participation in a formal weight loss program or significant weight loss (fluctuation >5% of total body weight) in the past 3 months.
- •Subjects with serious medical or psychiatric conditions
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: CP-945,598 (Drug)
Non-pharmacological weight loss program (NPP)
Other
干预措施: Non-pharmacological weight loss program (NPP) (Behavioral)
Low Calorie Diet
Other
干预措施: Low Calorie Diet (Behavioral)
结局指标
主要结局
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
时间窗: 14 months
次要结局
- To explore the effect of CP 954, 598 on: Waist circumference(14 months)
- To evaluate the safety and tolerability of CP 945,598 urine and blood tests(14 months)
- To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin(14 months)
- To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale(14 months)
- To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview(14 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic PatientsObesityNCT00391196Pfizer975
终止
3 期
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And SafetyObesityNCT00375401Pfizer2,536
终止
3 期
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.ObesityNCT00396448Pfizer1,253
已完成
2 期
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese SubjectsObesityNCT00134199Pfizer282
终止
2 期
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of ObesityObesityNCT00367783Pfizer100