Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-04-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AMG 745 0.3 mg/kg
0.3 mg/kg AMG 745
AMG 745 0.3 mg/kg
AMG 745 0.3 mg/kg IV QW
AMG 745 1.0 mg/kg
1.0 mg/kg, AMG 745
AMG 745 1.0 mg/kg
AMG 745 1.0 mg/kg IV QW
Placebo
Placebo
Placebo
Placebo IV QW
AMG 745 3.0 mg/kg
3.0 mg/kg, AMG 745
AMG 745 3.0 mg/kg
AMG 745 3.0 mg/kg IV QW
Interventions
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AMG 745 0.3 mg/kg
AMG 745 0.3 mg/kg IV QW
AMG 745 1.0 mg/kg
AMG 745 1.0 mg/kg IV QW
AMG 745 3.0 mg/kg
AMG 745 3.0 mg/kg IV QW
Placebo
Placebo IV QW
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20080733
Identifier Type: -
Identifier Source: org_study_id
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