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NCT00143416 Clinical Trial

Long Term Study With B2036-PEG

Acromegaly Clinical Trial

Official title:
Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143416
Other study ID # A6291011
Secondary ID
Status Completed
Phase Phase 3
First received September 1, 2005
Last updated July 24, 2008
Start date April 2004
Est. completion date July 2007

Study information
Verified date July 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pegvisomant

Locations
Country Name City State
Japan Pfizer Investigational Site Bonkyo-ku Tokyo
Japan Pfizer Investigational Site Gakuhara, Kishiwada, Osaka
Japan Pfizer Investigational Site Hamamatsu-shi Shizuoka-ken
Japan Pfizer Investigational Site Kobe City Hyogo Pref
Japan Pfizer Investigational Site Kozukue-cho, Kouhoku-ku, Yokohama-shi Kanagawa
Japan Pfizer Investigational Site Kyoto
Japan Pfizer Investigational Site Sannomaru-cho, Naka-ku, Nagoya-shi
Japan Pfizer Investigational Site Shinjuku-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary PK/PD evaluation
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