Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults
NCT00527046
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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
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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Descriptive Information | ||||
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Brief Title ICMJE | Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults | |||
Official Title ICMJE | A Randomized, Double Blind, Placebo Controlled, Five Parallel Group Study Of The Effect Of CP-424,391 On Physical Performance And Body Composition In Older Subjects | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: CP-424,391 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 396 | |||
Original Enrollment ICMJE | 395 | |||
Actual Study Completion Date ICMJE | October 2001 | |||
Actual Primary Completion Date | October 2001 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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 | |||
Sex/Gender ICMJE |
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Ages ICMJE | 65 Years to 84 Years (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00527046 | |||
Other Study ID Numbers ICMJE | A257-102 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |