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A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
This study has been completed.
First Received: September 4, 2003   Last Updated: April 3, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00068042
  Purpose

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 Intervention Phase
Acromegaly
 Drug: Pegvisomant
Drug: Sandostatin LAR
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Resource links provided by NLM:

Drug Information available for: Octreotide acetate Octreotide
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: April 2003
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068042

  Hide Study Locations
Locations
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, PR
Pfizer Investigational Site
Curitiba, PR, Brazil, 80030-110
Brazil, RJ
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 21941-590
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Brazil, SP
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
Essen, Germany, 45147
Pfizer Investigational Site
Marburg, Germany, 35043
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Hamburg, Germany, 22767
Pfizer Investigational Site
Dresden, Germany, 01307
Greece
Pfizer Investigational Site
Piraeus, Greece, 18537
Greece, Attika/Greece
Pfizer Investigational Site
Athens, Attika/Greece, Greece, 10676
Ireland
Pfizer Investigational Site
Dublin 9, Ireland
Pfizer Investigational Site
Cork, Ireland
Italy
Pfizer Investigational Site
Torino, Italy
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Napoli, Italy
Pfizer Investigational Site
Milano, Italy, 20122
Norway
Pfizer Investigational Site
Oslo, Norway, 0027
Spain
Pfizer Investigational Site
Madrid, Spain, 28035
Pfizer Investigational Site
Sevilla, Spain, 41013
Spain, Barcelona
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08906
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Pfizer Investigational Site
Linkoping, Sweden, 581 85
United Kingdom
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
Pfizer Investigational Site
Leeds, United Kingdom, LS1 3EX
Pfizer Investigational Site
London, United Kingdom, SE1 7EH
United Kingdom, Ireland
Pfizer Investigational Site
Belfast, Ireland, United Kingdom, BT12 6BA
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
Link to ClinicalStudyResults.org Posting:  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: PEGA-0435-003, A6291004
Study First Received: September 4, 2003
Last Updated: April 3, 2008
ClinicalTrials.gov Identifier: NCT00068042     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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