NCT00134199已完成2 期
A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 282
- 试验地点
- 16
- 主要终点
- Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
研究概览
简要总结
To evaluate the effect of 6-month administration of CP-945,598 on:
- weight loss and waist circumference,
- blood pressure, cholesterol, glucose
- other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP
- the relationship between the concentration of the drug on the blood and the above parameters
- physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression
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
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
- •Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
- •Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional
- •co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)];
排除标准
- •Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
- •Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
- •Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
- •Subjects on prescription and non-prescription appetite or weight modifying drugs
结局指标
主要结局
Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
次要结局
- Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ
研究者
研究点 (16)
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