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

Aging Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527046
• Other study ID #: A257-102
• Status: Terminated
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: January 30, 2012
• Start date: December 1999
• Est. completion date: October 2001

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 396
• Est. completion date: October 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Frail Older Adults

Intervention

Drug:
• CP-424,391

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	Palo Alto	California
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent increase in lean (non fat) body mass.		Measured by DXA at BL 3, 6, 12, and 24 months
Primary	Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min).		Measured at BL, 3, 6, 12, and 24 months
Secondary	Pharmacokinetics, blood hormones and biomarkers		(BL,3,6,12,24 months)
Secondary	Tape measurement of size of arm and leg muscles, waist, and hip		(BL,3,6,12,24 months)
Secondary	IGF-1 and GH levels		(1,2,18 months)
Secondary	Overnight GH profile in a subset		(2,18 months)
Secondary	Muscle strength		(BL,3,6,12,24 months)
Secondary	Questionnaires on general health, depression, mental status, sleep and activities of daily living		(BL,3,6,12,24 months)
Secondary	Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line)		(BL,3,6,12,24 months)

External Links

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