Pegvisomant And Sandostatin LAR Combination Study

Completed · Phase 4

Conditions studied: Acromegaly

In brief

The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

Key facts

Study ID

NCT00068029

Run by

Pfizer

People needed

75

Starts

2003-10-01

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
• Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
• Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment

You may not qualify if…

• Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
• Patients on current medical therapy other than Sandostatin LAR
• AST/ALT >= 3xULN (upper limits 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
• Radiotherapy within 12 months of entering the study

Where it is running

• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Chapel Hill, North Carolina, United States
• Pfizer Investigational Site — Charlottesville, Virginia, United States
• Pfizer Investigational Site — Darlinghurst, New South Wales, Australia
• Pfizer Investigational Site — Fitzroy, Victoria, Australia
• Pfizer Investigational Site — Fizroy, Victoria, Australia
• Pfizer Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Montpellier, France
• Pfizer Investigational Site — Nice, France
• Pfizer Investigational Site — Berlin, Germany
• Pfizer Investigational Site — Dresden, Germany
• Pfizer Investigational Site — Hanover, Germany
• Pfizer Investigational Site — Genova, Italy
• Pfizer Investigational Site — Messina, Italy
• Pfizer Investigational Site — Milan, Italy
• Pfizer Investigational Site — Torino, Italy
• Pfizer Investigational Site — Mexico City, Mexico City, Mexico
• Pfizer Investigational Site — Col La Raza, Mexico DF, Mexico
• Pfizer Investigational Site — Nijmegen, Netherlands
• Pfizer Investigational Site — Oslo, Norway

Full record on ClinicalTrials.gov

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