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Long Term Study With B2036-PEG

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ClinicalTrials.gov Identifier: NCT00143416
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : July 29, 2008
Information provided by:

Brief Summary:
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pegvisomant Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Study Start Date : April 2004
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Pegvisomant
U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly

Secondary Outcome Measures :
  1. PK/PD evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143416

Pfizer Investigational Site
Kobe City, Hyogo Pref, Japan, 650-0017
Pfizer Investigational Site
Kozukue-cho, Kouhoku-ku, Yokohama-shi, Kanagawa, Japan, 222-0036
Pfizer Investigational Site
Hamamatsu-shi, Shizuoka-ken, Japan, 431-3124
Pfizer Investigational Site
Bonkyo-ku, Tokyo, Japan, 113-0022
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan, 162-8666
Pfizer Investigational Site
Gakuhara, Kishiwada, Osaka, Japan, 596-8501
Pfizer Investigational Site
Kyoto, Japan, 612-8555
Pfizer Investigational Site
Sannomaru-cho, Naka-ku, Nagoya-shi, Japan, 460-0001
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00143416     History of Changes
Other Study ID Numbers: A6291011
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases