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

NCT00068042 | Completed Phase 4

• 2 other identifiers: PEGA-0435-003A6291004
• Study Type: interventional
• Target: 100
• Locations: 13 countries
• Sites: 55

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Pegvisomant DRUG

Sandostatin LAR DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (55)

Pfizer Investigational Site

Los Angeles, California, 90048, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, 02114, United States

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Ann Arbor, Michigan, 48109-0030, United States

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Ann Arbor, Michigan, 48109-0108, United States

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New York, New York, 10032, United States

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Chapel Hill, North Carolina, 27599-7600, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97239, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Houston, Texas, 77030, United States

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Charlottesville, Virginia, 22908, United States

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Darlinghurst, New South Wales, 2010, Australia

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Westmead, New South Wales, 2145, Australia

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Fitzroy, Victoria, 3165, Australia

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Heidelberg, Victoria, 3084, Australia

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Curitiba, Paraná, 80030-110, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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São Paulo, São Paulo, 05403-060, Brazil

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Edmonton, Alberta, T6G 2S2, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Montreal, Quebec, H2L 2W5, Canada

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Le Kremlin-Bicêtre, 94275, France

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Pessac, 33604, France

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Berlin, 10117, Germany

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Dresden, 01307, Germany

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Essen, 45147, Germany

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Hamburg, 22767, Germany

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Heidelberg, 69120, Germany

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Marburg, 35043, Germany

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Athens, Attika/Greece, 10676, Greece

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Piraeus, 18537, Greece

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Cork, Ireland

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Dublin, Ireland

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Genova, 16132, Italy

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Milan, 20122, Italy

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Napoli, Italy

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Roma, 00168, Italy

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Torino, Italy

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Oslo, 0027, Norway

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Badalona, Barcelona, 08916, Spain

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L'Hospitalet de Llobregat, Barcelona, 08906, Spain

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Madrid, Madrid, 28035, Spain

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Seville, Sevilla, 41013, Spain

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Belfast, Ireland, BT12 6BA, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Pfizer Investigational Site

London, EC1A 7BE, United Kingdom

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Pfizer Investigational Site

London, SE1 7EH, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2003
• First Posted: September 8, 2003
• Study Start: April 1, 2003
• Study Completion: May 1, 2006
• Last Updated: April 7, 2008

Record last verified: 2008-04

Locations

BR (4); AU (4); NO (1); ES (4); DE (6); CA (4); FR (2); GR (2); IE (2); SE (4); GB (4); US (13); IT (5)