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Long Term Study With B2036-PEG

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143416
First received: September 1, 2005
Last updated: July 24, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Acromegaly
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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143416

Locations
Japan
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 25, 2014