AMG 745 in Subjects With Age-associated Muscle Loss

NCT ID: NCT00975104

Last Updated: 2018-10-04

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Age-associated Muscle Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AMG 745 0.3 mg/kg

0.3 mg/kg AMG 745

Group Type EXPERIMENTAL

AMG 745 0.3 mg/kg

Intervention Type DRUG

AMG 745 0.3 mg/kg IV QW

AMG 745 1.0 mg/kg

1.0 mg/kg, AMG 745

Group Type EXPERIMENTAL

AMG 745 1.0 mg/kg

Intervention Type DRUG

AMG 745 1.0 mg/kg IV QW

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo IV QW

AMG 745 3.0 mg/kg

3.0 mg/kg, AMG 745

Group Type EXPERIMENTAL

AMG 745 3.0 mg/kg

Intervention Type DRUG

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

Intervention Type DRUG

AMG 745 1.0 mg/kg

AMG 745 1.0 mg/kg IV QW

Intervention Type DRUG

AMG 745 3.0 mg/kg

AMG 745 3.0 mg/kg IV QW

Intervention Type DRUG

Placebo

Placebo IV QW

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

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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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20080733

Identifier Type: -

Identifier Source: org_study_id

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