A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
NCT ID: NCT00068042
Last Updated: 2008-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2003-04-30
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Pegvisomant
Sandostatin LAR
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Chicago, Illinois, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Darlinghurst, New South Wales, Australia
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Westmead, New South Wales, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Le Kremlin-Bicêtre, , France
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Pessac, , France
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Marburg, , Germany
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Athens, Attika/Greece, Greece
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Piraeus, , Greece
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Cork, , Ireland
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Dublin, , Ireland
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Roma, , Italy
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Torino, , Italy
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Oslo, , Norway
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Badalona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Madrid, Madrid, Spain
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Seville, Sevilla, Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Belfast, Ireland, United Kingdom
Pfizer Investigational Site
Leeds, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6291004
Identifier Type: -
Identifier Source: secondary_id
PEGA-0435-003
Identifier Type: -
Identifier Source: org_study_id