Long Term Study With B2036-PEG

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NCT00143416

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Study Location
Pfizer Investigational Site
Kobe City, Hyogo Pref, 650-0017, Japan
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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
20-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

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


- Switching to other therapeutic methods for acromegaly

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long Term Study With B2036-PEG
Official Title  ICMJE Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Brief Summary Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE Drug: Pegvisomant
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: September 1, 2005)		16
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

Exclusion Criteria:

  • Switching to other therapeutic methods for acromegaly
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143416
Other Study ID Numbers  ICMJE A6291011
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 CenterPfizer
PRS Account Pfizer
Verification Date July 2008

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