Pegvisomant And Sandostatin LAR Combination Study

Condition(s) targeted: Acromegaly

Intervention: Pegvisomant/ Sandostatin LAR (Drug); Sandostatin LAR (Drug); Pegvisomant (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of subjects experiencing treatment-emergent adverse events across the duration fo the study

Secondary outcome: Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Pfizer Investigational Site, Montpellier Cedex 34295, France

Pfizer Investigational Site, Nice Cedex 06202, France

Pfizer Investigational Site, Hannover, Germany

Pfizer Investigational Site, Dresden 01307, Germany

Pfizer Investigational Site, Berlin 10117, Germany

Pfizer Investigational Site, Torino, Italy

Pfizer Investigational Site, Messina 98122, Italy

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Milano 20162, Italy

Pfizer Investigational Site, Nijmegen 6500 GA, Netherlands

Pfizer Investigational Site, Oslo 0027, Norway

Pfizer Investigational Site, Madrid 28035, Spain

Pfizer Investigational Site, London EC1A 7BE, United Kingdom

Pfizer Investigational Site, Oxford OX3 7LJ, United Kingdom

Pfizer Investigational Site, Manchester M20 4BX, United Kingdom

Pfizer Investigational Site, Leeds LS1 3EX, United Kingdom

Pfizer Investigational Site, London SE1 7EH, United Kingdom

Pfizer Investigational Site, Belfast, Antrim BT12 6BA, United Kingdom

Pfizer Investigational Site, Hospitalet de Llobregat, Barcelona 08906, Spain

Pfizer Investigational Site, Los Angeles, California 90048, United States

Pfizer Investigational Site, Mexico, DF 06720, Mexico

Pfizer Investigational Site, Col La Raza, MEXICO DF 02990, Mexico

Pfizer Investigational Site, Boston, Massachusetts 02114, United States

Pfizer Investigational Site, Darlinghurst, New South Wales 2010, Australia

Pfizer Investigational Site, Chapel Hill, North Carolina 27599-7600, United States

Pfizer Investigational Site, Halifax, Nova Scotia B3H 1V7, Canada

Pfizer Investigational Site, Halifax, Nova Scotia B3H 2Y9, Canada

Pfizer Investigational Site, Toronto, Ontario M5G 1X5, Canada

Pfizer Investigational Site, Rio de Janeiro, RJ 21941-590, Brazil

Pfizer Investigational Site, São Paulo, SP 05403-060, Brazil

Pfizer Investigational Site, Fitzroy, Victoria 3165, Australia

Pfizer Investigational Site, Fizroy, Victoria 3165, Australia

Pfizer Investigational Site, Charlottesville, Virginia 22908, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: October 2003
Ending date: May 2006
Last updated: April 3, 2008