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

Phase 2

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: placebo; Drug: AC2592

• Registration Number: NCT00099580
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-12-17
• Study First Submitted QC: 2004-12-17
• Study First Posted: 2004-12-20
• Study Start: 2005-03
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2014-12
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	AC2592	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States