Pegvisomant And Sandostatin LAR Combination Study
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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: NCT00068029 |
Recruitment Status :
Completed
First Posted : September 5, 2003
Last Update Posted : April 7, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Pegvisomant/ Sandostatin LAR Drug: Sandostatin LAR Drug: Pegvisomant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2003 |
Actual Study Completion Date : | May 2006 |

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

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

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): NCT00068029
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90048 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Chapel Hill, North Carolina, United States, 27599-7600 | |
United States, Virginia | |
Pfizer Investigational Site | |
Charlottesville, Virginia, United States, 22908 | |
Australia, New South Wales | |
Pfizer Investigational Site | |
Darlinghurst, New South Wales, Australia, 2010 | |
Australia, Victoria | |
Pfizer Investigational Site | |
Fitzroy, Victoria, Australia, 3165 | |
Pfizer Investigational Site | |
Fizroy, Victoria, Australia, 3165 | |
Brazil | |
Pfizer Investigational Site | |
Rio de Janeiro, RJ, Brazil, 21941-590 | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil, 05403-060 | |
Canada, Nova Scotia | |
Pfizer Investigational Site | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Pfizer Investigational Site | |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Toronto, Ontario, Canada, M5G 1X5 | |
France | |
Pfizer Investigational Site | |
Montpellier Cedex, France, 34295 | |
Pfizer Investigational Site | |
Nice Cedex, France, 06202 | |
Germany | |
Pfizer Investigational Site | |
Berlin, Germany, 10117 | |
Pfizer Investigational Site | |
Dresden, Germany, 01307 | |
Pfizer Investigational Site | |
Hannover, Germany | |
Italy | |
Pfizer Investigational Site | |
Genova, Italy, 16132 | |
Pfizer Investigational Site | |
Messina, Italy, 98122 | |
Pfizer Investigational Site | |
Milano, Italy, 20162 | |
Pfizer Investigational Site | |
Torino, Italy | |
Mexico | |
Pfizer Investigational Site | |
Mexico, DF, Mexico, 06720 | |
Pfizer Investigational Site | |
Col La Raza, Mexico Df, Mexico, 02990 | |
Netherlands | |
Pfizer Investigational Site | |
Nijmegen, Netherlands, 6500 GA | |
Norway | |
Pfizer Investigational Site | |
Oslo, Norway, 0027 | |
Spain | |
Pfizer Investigational Site | |
Hospitalet de Llobregat, Barcelona, Spain, 08906 | |
Pfizer Investigational Site | |
Madrid, Spain, 28035 | |
United Kingdom | |
Pfizer Investigational Site | |
Belfast, Antrim, 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 | |
Pfizer Investigational Site | |
Manchester, United Kingdom, M20 4BX | |
Pfizer Investigational Site | |
Oxford, United Kingdom, OX3 7LJ |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
ClinicalTrials.gov Identifier: | NCT00068029 |
Other Study ID Numbers: |
PEGA-0435-005 A6291006 |
First Posted: | September 5, 2003 Key Record Dates |
Last Update Posted: | April 7, 2008 |
Last Verified: | April 2008 |
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 |