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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014