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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:
ClinicalTrials.gov Identifier:
NCT00099580
First Posted: December 20, 2004
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by AstraZeneca:

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 ]
  • 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 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099580


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099580     History of Changes
Other Study ID Numbers: 2592-101 (PROCLAIM)
First Submitted: December 17, 2004
First Posted: December 20, 2004
Last Update Posted: January 19, 2015
Last Verified: December 2014

Keywords provided by AstraZeneca:
Congestive Heart Failure
AC2592
GLP-1
Amylin
metabolic abnormality

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases