Status:
COMPLETED
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Lead Sponsor:
AstraZeneca
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year)...
Eligibility Criteria
Inclusion
- Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
- Male, or female and meets all the following criteria:
- Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
- 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
- Is expected to require or undergo treatment with any exclusionary medication.
- Is undesirable as a study participant as judged by the investigator
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00819234
Start Date
November 1 2008
End Date
November 1 2009
Last Update
April 15 2015
Active Locations (33)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Phoenix, Arkansas, United States
3
Research Site
Santa Rosa, California, United States
4
Research Site
Walnut Creek, California, United States