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A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally healthy elderly men and women who are at risk of becoming frail.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-424,391 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent increase in lean (non fat) body mass. | Measured by DXA at BL 3, 6, 12, and 24 months | |
| Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min). | Measured at BL, 3, 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, blood hormones and biomarkers | (BL,3,6,12,24 months) | |
| Tape measurement of size of arm and leg muscles, waist, and hip | (BL,3,6,12,24 months) | |
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Inclusion Criteria:
65-84 years old, BMI < 30, at risk for functional decline based on SF-36, Instrumental Activities of Daily Living (per Nagy's), or 2 or more falls in prior 2 years
Exclusion Criteria:
Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Palo Alto | California | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19174493 | Derived | White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K, Wei JY, Hoffman AR, Salvatori R, Ettinger MP, Morey MC, Blackman MR, Merriam GR; Capromorelin Study Group. Effects of an oral growth hormone secretagogue in older adults. J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| IGF-1 and GH levels |
| (1,2,18 months) |
| Overnight GH profile in a subset | (2,18 months) |
| Muscle strength | (BL,3,6,12,24 months) |
| Questionnaires on general health, depression, mental status, sleep and activities of daily living | (BL,3,6,12,24 months) |
| Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line) | (BL,3,6,12,24 months) |
| San Diego |
| California |
| United States |
| Pfizer Investigational Site | Hamden | Connecticut | United States |
| Pfizer Investigational Site | New Britain | Connecticut | United States |
| Pfizer Investigational Site | Lake Worth | Florida | United States |
| Pfizer Investigational Site | Baltimore | Maryland | United States |
| Pfizer Investigational Site | Boston | Massachusetts | United States |
| Pfizer Investigational Site | Rochester | New York | United States |
| Pfizer Investigational Site | Durham | North Carolina | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | United States |
| Pfizer Investigational Site | San Antonio | Texas | United States |
| Pfizer Investigational Site | Seattle | Washington | United States |