NCT00527046终止2 期
A Randomized, Double Blind, Placebo Controlled, Five Parallel Group Study Of The Effect Of CP-424,391 On Physical Performance And Body Composition In Older Subjects
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 396
- 试验地点
- 12
- 主要终点
- Percent increase in lean (non fat) body mass.
研究概览
简要总结
A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally healthy elderly men and women who are at risk of becoming frail.
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
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-84 years old, BMI < 30, at risk for functional decline based on SF-36, Instrumental Activities of Daily Living (per Nagy's), or 2 or more falls in prior 2 years
排除标准
- •Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing
结局指标
主要结局
Percent increase in lean (non fat) body mass.
时间窗: Measured by DXA at BL 3, 6, 12, and 24 months
Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min).
时间窗: Measured at BL, 3, 6, 12, and 24 months
次要结局
- Pharmacokinetics, blood hormones and biomarkers((BL,3,6,12,24 months))
- Tape measurement of size of arm and leg muscles, waist, and hip((BL,3,6,12,24 months))
- IGF-1 and GH levels((1,2,18 months))
- Overnight GH profile in a subset((2,18 months))
- Muscle strength((BL,3,6,12,24 months))
- Questionnaires on general health, depression, mental status, sleep and activities of daily living((BL,3,6,12,24 months))
- Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line)((BL,3,6,12,24 months))
研究者
研究点 (12)
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