A 24 week off drug extension, parallel group, study assessing durability of effect on skeletal muscle strength and function following a 6-month double-blind, placebo controlled study evaluating bimagrumab in older adults with sarcopenia (InvestiGAIT extension)

ovartis Pharma Services AG0 个研究点目标入组 200 人开始时间: 2016年5月19日最近更新: 2019年4月30日

试验速览

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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 200

•This is an extension study and has the same exclusions as the core study. Because only participants who complete the core study are eligible for inclusion in this study, patients who no longer qualify or
•should be discontinued from the core study are excluded from participating in this study. Patients fulfilling the following criterion are not eligible for inclusion in this study:
•1. Any condition which should have led to treatment discontinuation per protocol in the core study
•No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients, within and across study sites.

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