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

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ClinicalTrials.gov Identifier: NCT00527046
Recruitment Status : Terminated
First Posted : September 10, 2007
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Frail Older Adults Drug: CP-424,391 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 1999
Actual Primary Completion Date : October 2001
Actual Study Completion Date : October 2001
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percent increase in lean (non fat) body mass. [ Time Frame: Measured by DXA at BL 3, 6, 12, and 24 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics, blood hormones and biomarkers [ Time Frame: (BL,3,6,12,24 months) ]
  2. Tape measurement of size of arm and leg muscles, waist, and hip [ Time Frame: (BL,3,6,12,24 months) ]
  3. IGF-1 and GH levels [ Time Frame: (1,2,18 months) ]
  4. Overnight GH profile in a subset [ Time Frame: (2,18 months) ]
  5. Muscle strength [ Time Frame: (BL,3,6,12,24 months) ]
  6. Questionnaires on general health, depression, mental status, sleep and activities of daily living [ Time Frame: (BL,3,6,12,24 months) ]
  7. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527046


Locations
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United States, California
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
San Diego, California, United States
United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States
Pfizer Investigational Site
New Britain, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Lake Worth, Florida, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, New York
Pfizer Investigational Site
Rochester, New York, United States
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Winston-salem, North Carolina, United States
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00527046    
Other Study ID Numbers: A257-102
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012