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

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Drug: AC2592; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States
      • Research Site
    • Mission Viejo, California, United States
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • Research Site
  • Florida
    • Jacksonville, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
  • Illinois
    • Peoria, Illinois, United States
      • Research Site
    • Springfield, Illinois, United States
      • Research Site
    • Winfield, Illinois, United States
      • Research Site
  • Kansas
    • Wichita, Kansas, United States
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Research Site
    • Shreveport, Louisiana, United States
      • Research Site
  • Maine
    • Auburn, Maine, United States
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • Research Site
  • Michigan
    • Detroit, Michigan, United States
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • Research Site
    • Durham, North Carolina, United States
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Research Site
    • Cleveland, Ohio, United States
      • Research Site
    • Columbus, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Oregon
    • Medford, Oregon, United States
      • Research Site
    • Portland, Oregon, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States
      • Research Site
  • Texas
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: December 17, 2004
• First Submitted That Met QC Criteria: December 17, 2004
• First Posted (Estimate): December 20, 2004

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: GLP-1; Amylin; Congestive Heart Failure; metabolic abnormality; AC2592
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2592-101 (PROCLAIM)