JPRN-jRCT2080223245已完成2 期
A 28 Week Randomized Withdrawal Extension of a Double-blind, Placebo-controlled, Parallel Group Study to Assess Durability of Effect on Skeletal Muscle Strength and Function Upon Withdrawal of Bimagrumab (higer dose level, intermediate dose level, lower dose level) in Older Adults With Sarcopenia
ovartis Pharma K.K.0 个研究点目标入组 240 人开始时间: 2016年6月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 70age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202).
排除标准
- •*Use of prohibited treatments as per recommendations outlined in protocol.
- •*History of severe hypersensitivity reaction in the core study (CBYM338E2202).
- •*History of breaking of the blind (inadvertently or for emergency reasons) in the core study (CBYM338E2202).
- •*History of adverse event(s) in the core study (CBYM338E2202) that in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study.
- •*Clinically significant abnormal liver function tests that would have resulted in discontinuation of study drug while participating in the core study(CBYM338E2202) as per protocol.
- •*Any medical condition or laboratory finding, which, in the opinion of the investigator prevents the subject from continuing participation in the study, may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk to the subject in administering bimagrumab.
- •Other protocol defined exclusion criteria may apply.
研究者
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