Long Term Study With B2036-PEG
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143416
First received: September 1, 2005
Last updated: July 24, 2008
Last verified: July 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | July 24, 2008 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00143416 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
PK/PD evaluation | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Acromegaly | ||||
| Intervention ICMJE | Drug: Pegvisomant | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00143416 | ||||
| Other Study ID Numbers ICMJE | A6291011 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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