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

NCT ID: NCT00099580

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-09-30

Brief Summary

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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

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AC2592

Intervention Type DRUG

continuous subcutaneous infusion (via pump), dose based on subject body weight

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

continuous subcutaneous infusion (via pump), dose based on subject body weight

Interventions

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AC2592

continuous subcutaneous infusion (via pump), dose based on subject body weight

Intervention Type DRUG

placebo

continuous subcutaneous infusion (via pump), dose based on subject body weight

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Porter, MD

Role: STUDY_DIRECTOR

Amylin Pharmaceuticals, LLC.

Locations

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Research Site

Beverly Hills, California, United States

Site Status

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Mission Viejo, California, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Peoria, Illinois, United States

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Springfield, Illinois, United States

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Winfield, Illinois, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Auburn, Maine, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Lincoln, Nebraska, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Countries

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United States

Other Identifiers

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2592-101 (PROCLAIM)

Identifier Type: -

Identifier Source: org_study_id

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