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

NCT ID: NCT00527046

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2001-10-31

Brief Summary

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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

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Conditions

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Aging Frail Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CP-424,391

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Palo Alto, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Hamden, Connecticut, United States

Site Status

Pfizer Investigational Site

New Britain, Connecticut, United States

Site Status

Pfizer Investigational Site

Lake Worth, Florida, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

Boston, Massachusetts, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19174493 (View on PubMed)

Related Links

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Other Identifiers

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A257-102

Identifier Type: -

Identifier Source: org_study_id

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