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

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

- 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
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

- 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

NCT00068042
Pfizer
Completed
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

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A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acromegaly
  • Drug: Pegvisomant
  • Drug: Sandostatin LAR
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2006
Not Provided

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
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,   Greece,   Ireland,   Italy,   Norway,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00068042
PEGA-0435-003
A6291004
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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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