PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
PROCLAIM: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Examine the Effects of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
1 other identifier
interventional
61
1 country
29
Brief Summary
This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2005
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedStudy Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJanuary 19, 2015
December 1, 2014
1.5 years
December 17, 2004
January 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
6 weeks
To assess the effect of AC2592 administered by continuous subcutaneous infusion on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
6 weeks
Secondary Outcomes (1)
To assess the effect of AC2592 administered by continuous subcutaneous infusion on pharmacokinetics, pharmacodynamics, and clinical outcomes in adult subjects with chronic congestive heart failure.
6 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy.
- 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.
You may not qualify if:
- Has received metformin or nesiritide within 2 weeks prior to screening visit.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
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
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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
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Lincoln, Nebraska, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Start
March 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
January 19, 2015
Record last verified: 2014-12