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CompletedNCT00099580Updated Jan 19, 2015

PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure

A Phase 2 interventional study of AC2592 and placebo in Congestive Heart Failure, sponsored by AstraZeneca. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Congestive Heart Failure

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Keywords

  • Congestive Heart Failure
  • AC2592
  • GLP-1
  • Amylin
  • metabolic abnormality
03

In context

Heart Failure

5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 61 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • 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 Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    1

    Drug: AC2592

  • Placebo comparator
    2

    Drug: placebo

Interventions

  • DrugAC2592

    continuous subcutaneous infusion (via pump), dose based on subject body weight

  • Drugplacebo

    continuous subcutaneous infusion (via pump), dose based on subject body weight

06

What researchers measure

Primary outcomes

  1. To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.

    Time frame: 6 weeks

  2. 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.

    Time frame: 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.

    Time frame: 6 weeks

07

Study locations

29 sites
  • Research Site
    Beverly Hills, California, United States
  • Research Site
    Mission Viejo, California, United States
  • Research Site
    New Haven, Connecticut, United States
  • Research Site
    Washington, 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
  • Research Site
    Cincinnati, Ohio, United States
  • Research Site
    Cleveland, Ohio, United States
  • Research Site
    Columbus, Ohio, United States
  • Research Site
    Oklahoma City, Oklahoma, United States
  • Research Site
    Medford, Oregon, United States
  • Research Site
    Portland, Oregon, United States
  • Research Site
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00099580
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 20, 2004
Start date
Mar 2005
Primary completion
Sep 2006
Completion
Sep 2006
Last update
Jan 19, 2015

Study contacts

Lisa Porter, MD
study director · Amylin Pharmaceuticals, LLC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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