Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
NCT ID: NCT00819234
Last Updated: 2015-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
274 participants
INTERVENTIONAL
2008-11-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo
placebo pramlintide and placebo metreleptin twice daily
2
Pramlintide and 1.25mg Metreleptin
Pramlintide and Metreleptin
Subcutaneous injection, twice daily
3
Pramlintide and 2.5mg Metreleptin
Pramlintide and Metreleptin
Subcutaneous injection, twice daily
4
Pramlintide and 5.0mg Metreleptin
Pramlintide and Metreleptin
Subcutaneous injection, twice daily
Interventions
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Placebo
placebo pramlintide and placebo metreleptin twice daily
Pramlintide and Metreleptin
Subcutaneous injection, twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male, or female and meets all the following criteria:
1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
* Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria
* Is undesirable as a study participant as judged by the investigator
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Chan, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arkansas, United States
Research Site
Santa Rosa, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Denver, Colorado, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Kansas City, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Anderson, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Bellingham, Washington, United States
Research Site
Olympia, Washington, United States
Countries
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References
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Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.
Other Identifiers
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DFA102E
Identifier Type: -
Identifier Source: org_study_id
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