A 24-week off drug extension study assessing the durability of effect of bimagrumab in older adults with sarcopenia previously participating in the 6-month core study
- Conditions
- SarcopeniaTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]MedDRA version: 20.0 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2015-000471-27-DK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method