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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00068042
Recruitment Status : Completed
First Posted : September 8, 2003
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pegvisomant Drug: Sandostatin LAR Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Study Start Date : April 2003
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)

Secondary Outcome Measures :
  1. The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068042


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Locations
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United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
Pfizer Investigational Site
Chicago, Illinois, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0030
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0108
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22908
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Pfizer Investigational Site
Fitzroy, Victoria, Australia, 3165
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Brazil
Pfizer Investigational Site
Curitiba, PR, Brazil, 80030-110
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 05403-060
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2S2
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 2W5
France
Pfizer Investigational Site
Le Kremlin Bicetre, France, 94275
Pfizer Investigational Site
Pessac, France, 33604
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Essen, Germany, 45147
Pfizer Investigational Site
Hamburg, Germany, 22767
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Marburg, Germany, 35043
Greece
Pfizer Investigational Site
Athens, Attika/Greece, Greece, 10676
Pfizer Investigational Site
Piraeus, Greece, 18537
Ireland
Pfizer Investigational Site
Cork, Ireland
Pfizer Investigational Site
Dublin 9, Ireland
Italy
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Milano, Italy, 20122
Pfizer Investigational Site
Napoli, Italy
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Torino, Italy
Norway
Pfizer Investigational Site
Oslo, Norway, 0027
Spain
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08906
Pfizer Investigational Site
Madrid, Spain, 28035
Pfizer Investigational Site
Sevilla, Spain, 41013
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Pfizer Investigational Site
Uppsala, Sweden, 751 85
United Kingdom
Pfizer Investigational Site
Belfast, Ireland, United Kingdom, BT12 6BA
Pfizer Investigational Site
Leeds, United Kingdom, LS1 3EX
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
Pfizer Investigational Site
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00068042     History of Changes
Other Study ID Numbers: PEGA-0435-003
A6291004
First Posted: September 8, 2003    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents