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Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00259038
First received: November 28, 2005
Last updated: August 29, 2006
Last verified: August 2006
  Purpose

The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.


Condition Intervention Phase
Heart Failure, Congestive
Heart Decompensation
Left Ventricular Failure
Myocardiopathies
Systolic or Diastolic Left Ventricular Dysfunction
Drug: Carperitide (human recombinant atrial natriuretic peptide)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

  Eligibility

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

Inclusion Criteria:

  • Subject is hospitalized with CHF (congestive heart failure
  • Subject has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mm Hg or higher.

Exclusion Criteria:

  • Subject has had a heart transplant
  • Subject requires mechanical ventilation or mechanical circulatory support
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259038

  Show 34 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: Biljana Pavlovic-Surjancev, MD, PhD Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259038     History of Changes
Other Study ID Numbers: 03-0-162
Study First Received: November 28, 2005
Last Updated: August 29, 2006
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Carperitide
Atrial Natriuretic Peptide
Treatment efficacy
Safety
Heart failure, Congestive
Pulmonary Artery Catheterization

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014