A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Completed · Phase 4

Conditions studied: Acromegaly

In brief

The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

Key facts

Study ID

NCT00068042

Run by

Pfizer

People needed

100

Starts

2003-04-01

Expected to finish

2006-05-01

Last updated by the study team

2008-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acromegaly
• IGF-I levels >=1.3xULN (upper limit of normal) at screening
• No history of radiotherapy or prior treatment with other drugs for acromegaly
• Minimum of two months must have elapsed post surgery prior to screening

You may not qualify if…

• Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
• AST/ALT >= 3xULN (upper limit of normal)
• Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
• Visual field defects (except post surgical stable residual defects)
• Unable to self administer drug

Where it is running

• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Chapel Hill, North Carolina, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Charlottesville, Virginia, United States
• Pfizer Investigational Site — Darlinghurst, New South Wales, Australia
• Pfizer Investigational Site — Westmead, New South Wales, Australia
• Pfizer Investigational Site — Fitzroy, Victoria, Australia
• Pfizer Investigational Site — Heidelberg, Victoria, Australia
• Pfizer Investigational Site — Curitiba, Paraná, Brazil
• Pfizer Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Pfizer Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — Edmonton, Alberta, Canada
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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