Last updated date
ABOUT THIS STUDY
Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients
with acromegaly.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Acromegaly
Sex
Females and Males
Age
20-75 years
Inclusion Criteria
Show details
- Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).
Exclusion Criteria
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- Switching to other therapeutic methods for acromegaly
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Long Term Study With B2036-PEG | |||
Official Title ICMJE | Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG - | |||
Brief Summary | Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Acromegaly | |||
Intervention ICMJE | Drug: Pegvisomant | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 16 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143416 | |||
Other Study ID Numbers ICMJE | A6291011 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |