AMG 745 in Subjects With Age-associated Muscle Loss

This study has been withdrawn prior to enrollment.
(Amgen has chosen at this time not to continue with AMG 745 study 20080733)
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00975104
First received: September 10, 2009
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975104

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00975104     History of Changes
Other Study ID Numbers: 20080733
Study First Received: September 10, 2009
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014