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

January 30, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 84 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent increase in lean (non fat) body mass.
Time Frame: Measured by DXA at BL 3, 6, 12, and 24 months
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
Measured at BL, 3, 6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics, blood hormones and biomarkers
Time Frame: (BL,3,6,12,24 months)
(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)
(BL,3,6,12,24 months)
IGF-1 and GH levels
Time Frame: (1,2,18 months)
(1,2,18 months)
Overnight GH profile in a subset
Time Frame: (2,18 months)
(2,18 months)
Muscle strength
Time Frame: (BL,3,6,12,24 months)
(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)
(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)
(BL,3,6,12,24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (ACTUAL)

October 1, 2001

Study Completion (ACTUAL)

October 1, 2001

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (ESTIMATE)

September 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • A257-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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