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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00099580
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: AC2592 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1 Drug: AC2592
continuous subcutaneous infusion (via pump), dose based on subject body weight

Placebo Comparator: 2 Drug: placebo
continuous subcutaneous infusion (via pump), dose based on subject body weight




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099580


Locations
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United States, California
Research Site
Beverly Hills, California, United States
Research Site
Mission Viejo, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Tampa, Florida, United States
United States, Illinois
Research Site
Peoria, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Winfield, Illinois, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
United States, Maine
Research Site
Auburn, Maine, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Nebraska
Research Site
Lincoln, Nebraska, United States
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States
Research Site
Durham, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099580    
Other Study ID Numbers: 2592-101 (PROCLAIM)
First Posted: December 20, 2004    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: December 2014
Keywords provided by AstraZeneca:
Congestive Heart Failure
AC2592
GLP-1
Amylin
metabolic abnormality
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases