EUCTR2013-003439-31-CZ进行中（未招募）1 期
A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Must have had surgical fixation or arthroplasty for a fracture of the proximal femur as confirmed by radiography;
- •Must have completed surgical wound healing;
- •Must be able to complete a 4 m gait speed test;
- •Must weigh at least 35 kg.
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 245
排除标准
- •Must not have history of any other lower limb fractures in the past 6 months;
- •Must not have certain cardiovascular conditions;
- •Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc);
- •Must not have used high-dose corticosteroid medications for at least 3 months in the past year;
- •Other protocol-defined inclusion and exclusion criteria may apply
研究者
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