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

This study has been completed.
Sponsor:
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00099580
First received: December 17, 2004
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

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 Intervention Phase
Congestive Heart Failure
 Drug: AC2592
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: March 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099580

  Show 29 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Lisa Porter, MD, Study Director, Amylin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099580     History of Changes
Other Study ID Numbers: 2592-101 (PROCLAIM)
Study First Received: December 17, 2004
Last Updated: December 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
Congestive Heart Failure
AC2592
GLP-1
Amylin
metabolic abnormality

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013