Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT00975104
Status:
WITHDRAWN
Last Update Posted:
2018-10-04
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AMG 745 in Subjects With Age-associated Muscle Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594655', 'term': 'AMG 745'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Amgen has chosen at this time not to continue with AMG 745 study 20080733', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '12 Weeks'}]}, 'conditionsModule': {'keywords': ['Aging', 'Frailty', 'Sedentary', 'Immobilization', 'Atrophy', 'Muscle Wasting', 'Physical Activity'], 'conditions': ['Age-associated Muscle Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3\n* Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg\n* Walk speed ≤ 0.8 m/s (based on a 4 meter walk)\n\nExclusion Criteria:\n\n* Subject weight \\> 137 kg (300 lbs), or Body Mass Index (BMI) \\> 32 kg/m2\n* Primary muscle disease or myopathy\n* Recent immobilization, or major trauma to the legs within 6 months\n* Knee or hip replacement within 12 months or lower extremity amputation\n* Significant laboratory abnormalities\n* Significant comorbidities or medical history\n* Weight loss (intentional or unintentional) of \\> 5 kg in 12 weeks\n* Unable to complete an MRI scan'}, 'identificationModule': {'nctId': 'NCT00975104', 'briefTitle': 'AMG 745 in Subjects With Age-associated Muscle Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss', 'orgStudyIdInfo': {'id': '20080733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 745 0.3 mg/kg', 'description': '0.3 mg/kg AMG 745', 'interventionNames': ['Drug: AMG 745 0.3 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 745 1.0 mg/kg', 'description': '1.0 mg/kg, AMG 745', 'interventionNames': ['Drug: AMG 745 1.0 mg/kg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 745 3.0 mg/kg', 'description': '3.0 mg/kg, AMG 745', 'interventionNames': ['Drug: AMG 745 3.0 mg/kg']}], 'interventions': [{'name': 'AMG 745 0.3 mg/kg', 'type': 'DRUG', 'description': 'AMG 745 0.3 mg/kg IV QW', 'armGroupLabels': ['AMG 745 0.3 mg/kg']}, {'name': 'AMG 745 1.0 mg/kg', 'type': 'DRUG', 'description': 'AMG 745 1.0 mg/kg IV QW', 'armGroupLabels': ['AMG 745 1.0 mg/kg']}, {'name': 'AMG 745 3.0 mg/kg', 'type': 'DRUG', 'description': 'AMG 745 3.0 mg/kg IV QW', 'armGroupLabels': ['AMG 745 3.0 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV QW', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}