Status:
COMPLETED
PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
Lead Sponsor:
AstraZeneca
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 durin...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00099580
Start Date
March 1 2005
End Date
September 1 2006
Last Update
January 19 2015
Active Locations (29)
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1
Research Site
Beverly Hills, California, United States
2
Research Site
Mission Viejo, California, United States
3
Research Site
New Haven, Connecticut, United States
4
Research Site
Washington D.C., District of Columbia, United States