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Long Term Study With B2036-PEG

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 1, 2005
Last updated: July 24, 2008
Last verified: July 2008
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.

Condition Intervention Phase
Drug: Pegvisomant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • PK/PD evaluation

Estimated Enrollment: 16
Study Start Date: April 2004
Study Completion Date: July 2007

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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 Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00143416     History of Changes
Other Study ID Numbers: A6291011 
Study First Received: September 1, 2005
Last Updated: July 24, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 processed this record on October 21, 2016