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Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00527046
First received: September 6, 2007
Last updated: January 30, 2012
Last verified: January 2012

September 6, 2007
January 30, 2012
December 1999
October 2001   (final data collection date for primary outcome measure)
  • Percent increase in lean (non fat) body mass. [ Time Frame: 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). [ Time Frame: Measured at BL, 3, 6, 12, and 24 months ]
Same as current
Complete list of historical versions of study NCT00527046 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics, blood hormones and biomarkers [ Time Frame: (BL,3,6,12,24 months) ]
  • Tape measurement of size of arm and leg muscles, waist, and hip [ Time Frame: (BL,3,6,12,24 months) ]
  • IGF-1 and GH levels [ Time Frame: (1,2,18 months) ]
  • Overnight GH profile in a subset [ Time Frame: (2,18 months) ]
  • Muscle strength [ Time Frame: (BL,3,6,12,24 months) ]
  • Questionnaires on general health, depression, mental status, sleep and activities of daily living [ Time Frame: (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) [ Time Frame: (BL,3,6,12,24 months) ]
Same as current
Not Provided
Not Provided
 
Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Aging
  • Frail Older Adults
Drug: CP-424,391
Not Provided
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. Epub 2009 Jan 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
396
October 2001
October 2001   (final data collection date for primary outcome measure)

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

Both
65 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00527046
A257-102
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP