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Amgen has chosen at this time not to continue with AMG 745 study 20080733
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 745 0.3 mg/kg | Experimental | 0.3 mg/kg AMG 745 |
|
| AMG 745 1.0 mg/kg | Experimental | 1.0 mg/kg, AMG 745 |
|
| Placebo | Placebo Comparator | Placebo |
|
| AMG 745 3.0 mg/kg | Experimental | 3.0 mg/kg, AMG 745 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 745 0.3 mg/kg | Drug | AMG 745 0.3 mg/kg IV QW |
| |
| AMG 745 1.0 mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D057185 | Sedentary Behavior |
| D001284 | Atrophy |
| D009133 | Muscular Atrophy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C000594655 | AMG 745 |
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| Drug |
AMG 745 1.0 mg/kg IV QW |
|
| AMG 745 3.0 mg/kg | Drug | AMG 745 3.0 mg/kg IV QW |
|
| Placebo | Drug | Placebo IV QW |
|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |