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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00099580

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Drug: AC2592 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

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 :

Mar 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
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	District of Columbia	United States
5	Research Site	Jacksonville	Florida	United States
6	Research Site	Tampa	Florida	United States
7	Research Site	Peoria	Illinois	United States
8	Research Site	Springfield	Illinois	United States
9	Research Site	Winfield	Illinois	United States
10	Research Site	Wichita	Kansas	United States
11	Research Site	Baton Rouge	Louisiana	United States
12	Research Site	Shreveport	Louisiana	United States
13	Research Site	Auburn	Maine	United States
14	Research Site	Boston	Massachusetts	United States
15	Research Site	Detroit	Michigan	United States
16	Research Site	Lincoln	Nebraska	United States
17	Research Site	Chapel Hill	North Carolina	United States
18	Research Site	Durham	North Carolina	United States
19	Research Site	Cincinnati	Ohio	United States
20	Research Site	Cleveland	Ohio	United States
21	Research Site	Columbus	Ohio	United States
22	Research Site	Oklahoma City	Oklahoma	United States
23	Research Site	Medford	Oregon	United States
24	Research Site	Portland	Oregon	United States
25	Research Site	Philadelphia	Pennsylvania	United States
26	Research Site	Charleston	South Carolina	United States
27	Research Site	Knoxville	Tennessee	United States
28	Research Site	Dallas	Texas	United States
29	Research Site	Houston	Texas	United States