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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099580
• Other study ID #: 2592-101 (PROCLAIM)
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2004
• Last updated: January 16, 2015
• Start date: March 2005
• Est. completion date: September 2006

Study information

• Verified date: December 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• AC2592
continuous subcutaneous infusion (via pump), dose based on subject body weight
• placebo
continuous subcutaneous infusion (via pump), dose based on subject body weight

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.		6 weeks	No
Primary	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	No
Secondary	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	No