NCT00527046

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 1999

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1.8 years

First QC Date

September 6, 2007

Last Update Submit

January 30, 2012

Conditions

AgingFrail Older Adults

Outcome Measures

Primary Outcomes (2)

  • Percent increase in lean (non fat) body mass.

    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).

    Measured at BL, 3, 6, 12, and 24 months

Secondary Outcomes (7)

  • Pharmacokinetics, blood hormones and biomarkers

    (BL,3,6,12,24 months)

  • Tape measurement of size of arm and leg muscles, waist, and hip

    (BL,3,6,12,24 months)

  • IGF-1 and GH levels

    (1,2,18 months)

  • Overnight GH profile in a subset

    (2,18 months)

  • Muscle strength

    (BL,3,6,12,24 months)

  • +2 more secondary outcomes

Interventions

CP-424,391DRUG

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Palo Alto, California, United States

Location

Pfizer Investigational Site

San Diego, California, United States

Location

Pfizer Investigational Site

Hamden, Connecticut, United States

Location

Pfizer Investigational Site

New Britain, Connecticut, United States

Location

Pfizer Investigational Site

Lake Worth, Florida, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, United States

Location

Pfizer Investigational Site

Rochester, New York, United States

Location

Pfizer Investigational Site

Durham, North Carolina, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Location

Pfizer Investigational Site

San Antonio, Texas, United States

Location

Pfizer Investigational Site

Seattle, Washington, United States

Location

Related Publications (1)

  • 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.

    PMID: 19174493DERIVED

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

December 1, 1999

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

US(12)