Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults
This study has been terminated.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00527046
First received: September 6, 2007
Last updated: January 30, 2012
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Aging Frail Older Adults |
Drug: CP-424,391 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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) ]
| Enrollment: | 396 |
| Study Start Date: | December 1999 |
| Study Completion Date: | October 2001 |
| Primary Completion Date: | October 2001 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 65 Years to 84 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527046
Locations
| 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
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00527046 History of Changes |
| Other Study ID Numbers: | A257-102 |
| Study First Received: | September 6, 2007 |
| Last Updated: | January 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 17, 2013