NCT00975104撤回2 期
A Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Amgen
- 主要终点
- To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations
研究概览
简要总结
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3
- •Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg
- •Walk speed ≤ 0.8 m/s (based on a 4 meter walk)
排除标准
- •Subject weight > 137 kg (300 lbs), or Body Mass Index (BMI) > 32 kg/m2
- •Primary muscle disease or myopathy
- •Recent immobilization, or major trauma to the legs within 6 months
- •Knee or hip replacement within 12 months or lower extremity amputation
- •Significant laboratory abnormalities
- •Significant comorbidities or medical history
- •Weight loss (intentional or unintentional) of > 5 kg in 12 weeks
- •Unable to complete an MRI scan
研究组 & 干预措施
AMG 745 0.3 mg/kg
Experimental
0.3 mg/kg AMG 745
干预措施: AMG 745 0.3 mg/kg (Drug)
AMG 745 1.0 mg/kg
Experimental
1.0 mg/kg, AMG 745
干预措施: AMG 745 1.0 mg/kg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
AMG 745 3.0 mg/kg
Experimental
3.0 mg/kg, AMG 745
干预措施: AMG 745 3.0 mg/kg (Drug)
结局指标
主要结局
To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations
时间窗: 12 Weeks
次要结局
- To evaluate the effect of treatment with AMG 745 on muscle strength (hand grip strength) and function (gait speed, 10-step stair climb power, chair stand and 6 minute walk distance) and to evaluate the PK of AMG 745 following multiple IV administrations(12 Weeks)
研究者
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