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

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: NCT00068042
Recruitment Status : Completed
First Posted : September 8, 2003
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 4, 2003
First Posted Date  ICMJE September 8, 2003
Last Update Posted Date April 7, 2008
Study Start Date  ICMJE April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00068042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Official Title  ICMJE A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE
  • Drug: Pegvisomant
  • Drug: Sandostatin LAR
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)
100
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   France,   Germany,   Greece,   Ireland,   Italy,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00068042
Other Study ID Numbers  ICMJE PEGA-0435-003
A6291004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP