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Pegvisomant And Sandostatin LAR Combination Study

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00068029
Pfizer
Completed
Pegvisomant And Sandostatin LAR Combination Study

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Acromegaly
NCT00068029
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Pegvisomant And Sandostatin LAR Combination Study
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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Acromegaly
  • Drug: Pegvisomant/ Sandostatin LAR
  • Drug: Sandostatin LAR
  • Drug: Pegvisomant
Not Provided
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*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Netherlands,   Norway,   Spain,   United Kingdom,   United States
 
 
NCT00068029
PEGA-0435-005
A6291006
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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