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

AstraZeneca1 site in 1 country61 target enrollmentMarch 2005

ConditionsCongestive Heart Failure

InterventionsAC2592 placebo

DrugsAC2592 placebo

Overview

Phase: Phase 2
Intervention: AC2592
Conditions: Congestive Heart Failure
Sponsor: AstraZeneca
Enrollment: 61
Locations: 1
Primary Endpoint: To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

September 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

1

Intervention: AC2592

2

Intervention: placebo

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 6 weeks

Secondary Outcomes

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)