Status:
WITHDRAWN
AMG 745 in Subjects With Age-associated Muscle Loss
Lead Sponsor:
Amgen
Conditions:
Age-associated Muscle Loss
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Eligibility Criteria
Inclusion
- Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3
- Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg
- Walk speed ≤ 0.8 m/s (based on a 4 meter walk)
Exclusion
- Subject weight \> 137 kg (300 lbs), or Body Mass Index (BMI) \> 32 kg/m2
- Primary muscle disease or myopathy
- Recent immobilization, or major trauma to the legs within 6 months
- Knee or hip replacement within 12 months or lower extremity amputation
- Significant laboratory abnormalities
- Significant comorbidities or medical history
- Weight loss (intentional or unintentional) of \> 5 kg in 12 weeks
- Unable to complete an MRI scan
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00975104
Start Date
April 1 2010
End Date
August 1 2011
Last Update
October 4 2018
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