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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AC2592
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, AC2592, GLP-1, Amylin, metabolic abnormality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2004
Last Updated
January 16, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00099580
Brief Title
PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, AC2592, GLP-1, Amylin, metabolic abnormality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AC2592
Intervention Description
continuous subcutaneous infusion (via pump), dose based on subject body weight
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
continuous subcutaneous infusion (via pump), dose based on subject body weight
Primary Outcome Measure Information:
Title
To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
Time Frame
6 weeks
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Research Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Winfield
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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