- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143416
Long Term Study With B2036-PEG
July 24, 2008 updated by: Pfizer
Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
Study Overview
Study Type
Interventional
Enrollment
16
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gakuhara, Kishiwada, Osaka, Japan, 596-8501
- Pfizer Investigational Site
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Kyoto, Japan, 612-8555
- Pfizer Investigational Site
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Sannomaru-cho, Naka-ku, Nagoya-shi, Japan, 460-0001
- Pfizer Investigational Site
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Hyogo Pref
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Kobe City, Hyogo Pref, Japan, 650-0017
- Pfizer Investigational Site
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Kanagawa
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Kozukue-cho, Kouhoku-ku, Yokohama-shi, Kanagawa, Japan, 222-0036
- Pfizer Investigational Site
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Shizuoka-ken
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Hamamatsu-shi, Shizuoka-ken, Japan, 431-3124
- Pfizer Investigational Site
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Tokyo
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Bonkyo-ku, Tokyo, Japan, 113-0022
- Pfizer Investigational Site
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Shinjuku-ku, Tokyo, Japan, 162-8666
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
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Secondary Outcome Measures
Outcome Measure |
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PK/PD evaluation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
July 29, 2008
Last Update Submitted That Met QC Criteria
July 24, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6291011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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