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AgingPhase 2NCT00527046

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

A Phase 2 study testing CP-424,391 in people with Aging and Frail Older Adults, run by Pfizer at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 84 years
Conditions the study is for
Aging, Frail Older Adults
What is being tested?
CP-424,391
How many people
396 participants
Where
12 sitesUnited States
Study dates
Dec 1999to Oct 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 84 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Pfizer Investigational Site

    Baltimore, Maryland

  • Pfizer Investigational Site

    Boston, Massachusetts

  • Pfizer Investigational Site

    Durham, North Carolina

  • Pfizer Investigational Site

    Hamden, Connecticut

  • Pfizer Investigational Site

    Lake Worth, Florida

  • Pfizer Investigational Site

    New Britain, Connecticut

  • Pfizer Investigational Site

    Palo Alto, California

  • Pfizer Investigational Site

    Rochester, New York

  • Pfizer Investigational Site

    San Antonio, Texas

  • Pfizer Investigational Site

    San Diego, California

  • Pfizer Investigational Site

    Seattle, Washington

  • Pfizer Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

About this study

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

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.

Being tested
CP-424,391

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-424,391Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Measured by DXA at BL 3, 6, 12, and 24 months

  2. Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min).

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

Secondary outcomes (7)

  1. Pharmacokinetics, blood hormones and biomarkers

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

  2. Tape measurement of size of arm and leg muscles, waist, and hip

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

  3. IGF-1 and GH levels

    Measured: (1,2,18 months)

  4. Overnight GH profile in a subset

    Measured: (2,18 months)

  5. Muscle strength

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

  6. Questionnaires on general health, depression, mental status, sleep and activities of daily living

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

  7. Other physical performance tests including time to rise from a chair 5 times, balance tests (walking a straight line)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startDec 1999
  3. Primary completionOct 2001
  4. Study completionOct 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527046
Sponsor's protocol ID
A257-102
Status last verified
Jan 2012
First submitted
6 Sep 2007
Last updated
2 Feb 2012
Results posted
No

Publications

  • 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.

    PubMed 19174493

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-424,391 in people with Aging and Frail Older Adults, run by Pfizer at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent increase in lean (non fat) body mass. (time frame: Measured by DXA at BL 3, 6, 12, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527046, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.

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