A 28 week randomized withdrawal extension of a doubleblind, placebo-controlled, parallel group study to assess durability of effect on skeletal muscle strength and function upon withdrawal of bimagrumab 70, 210, 700 mg in older adults with sarcopenia

ovartis Pharma Services AG0 个研究点目标入组 240 人开始时间: 2016年5月9日最近更新: 2019年4月30日

研究概览

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•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).
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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 240

•- 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
•- Concurrent enrollment in a clinical trial involving an investigational drug or off- label use of a drug, or any other type of medical research judged to be scientifically or medically incompatible with this study (not including enrollment in BYM338E2202 core study).

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