Back to resultsLong Term Study With B2036-PEG
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Pegvisomant
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00143416
Brief Title
Long Term Study With B2036-PEG
Official Title
Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Primary Outcome Measure Information:
Title
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary Outcome Measure Information:
Title
PK/PD evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kobe City
State/Province
Hyogo Pref
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kozukue-cho, Kouhoku-ku, Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hamamatsu-shi
State/Province
Shizuoka-ken
ZIP/Postal Code
431-3124
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bonkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0022
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Pfizer Investigational Site
City
Gakuhara, Kishiwada, Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sannomaru-cho, Naka-ku, Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6291011&StudyName=Long%20Term%20Study%20with%20B2036-PEG
Description
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Learn more about this trial
Long Term Study With B2036-PEG
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