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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014