PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
NCT ID: NCT00099580
Last Updated: 2015-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2005-03-31
2006-09-30
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
DOUBLE
Study Groups
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1
AC2592
continuous subcutaneous infusion (via pump), dose based on subject body weight
2
placebo
continuous subcutaneous infusion (via pump), dose based on subject body weight
Interventions
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AC2592
continuous subcutaneous infusion (via pump), dose based on subject body weight
placebo
continuous subcutaneous infusion (via pump), dose based on subject body weight
Eligibility Criteria
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Inclusion Criteria
* Is able to perform a treadmill test.
* Has an HbA1c of \<= 11%.
* Is physically and mentally capable of operating the continuous subcutaneous infusion (CSCI) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement.
Exclusion Criteria
* Is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period.
* Has participated previously in a study using GLP-1, exenatide, or exenatide LAR.
* Is using a left ventricular assist device or other mechanical circulatory support.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Beverly Hills, California, United States
Research Site
Mission Viejo, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Peoria, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Winfield, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Auburn, Maine, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Durham, North Carolina, United States
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Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
Research Site
Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Countries
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Other Identifiers
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2592-101 (PROCLAIM)
Identifier Type: -
Identifier Source: org_study_id
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