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AMG 745 in Subjects With Age-associated Muscle Loss

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ClinicalTrials.gov Identifier: NCT00975104
Recruitment Status : Withdrawn (Amgen has chosen at this time not to continue with AMG 745 study 20080733)
First Posted : September 11, 2009
Last Update Posted : July 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss

Condition or disease Intervention/treatment Phase
Age-associated Muscle Loss Drug: AMG 745 0.3 mg/kg Drug: AMG 745 1.0 mg/kg Drug: AMG 745 3.0 mg/kg Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Study Start Date : April 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : August 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: AMG 745 0.3 mg/kg
0.3 mg/kg AMG 745
Drug: AMG 745 0.3 mg/kg
AMG 745 0.3 mg/kg IV QW
Experimental: AMG 745 1.0 mg/kg
1.0 mg/kg, AMG 745
Drug: AMG 745 1.0 mg/kg
AMG 745 1.0 mg/kg IV QW
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo IV QW
Experimental: AMG 745 3.0 mg/kg
3.0 mg/kg, AMG 745
Drug: AMG 745 3.0 mg/kg
AMG 745 3.0 mg/kg IV QW


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. To evaluate the effect of treatment with AMG 745 on muscle strength (hand grip strength) and function (gait speed, 10-step stair climb power, chair stand and 6 minute walk distance) and to evaluate the PK of AMG 745 following multiple IV administrations [ Time Frame: 12 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975104


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00975104     History of Changes
Other Study ID Numbers: 20080733
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by Amgen:
Aging
Frailty
Sedentary
Immobilization
Atrophy
Muscle Wasting
Physical Activity