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

NCT00527046

Last updated date
Study Location
Pfizer Investigational Site
Palo Alto, California, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aging, Frail Older Adults
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-84 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Aging, Frail Older AdultsEffects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults NCT00527046
  1. Palo Alto, California
  2. San Diego, California
  3. Hamden, Connecticut
  4. New Britain, Connecticut
  5. Lake Worth, Florida
  6. Baltimore, Maryland
  7. Boston, Massachusetts
  8. Rochester, New York
  9. Durham, North Carolina
  10. Winston-salem, North Carolina
  11. San Antonio, Texas
  12. Seattle, Washington
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Aging
  • Frail Older Adults
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
 (submitted: January 30, 2012)
396
Original Enrollment  ICMJE
 (submitted: September 6, 2007)
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
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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