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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00259038
First received: November 28, 2005
Last updated: December 15, 2015
Last verified: December 2015
  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 Daiichi Sankyo Inc.:

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Daiichi Sankyo Inc.
Investigators
Study Director: Biljana Pavlovic-Surjancev, MD, PhD Astellas Pharma US, Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00259038     History of Changes
Other Study ID Numbers: 03-0-162 
Study First Received: November 28, 2005
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Daiichi Sankyo Inc.:
Carperitide
Atrial Natriuretic Peptide
Treatment efficacy
Safety
Heart failure, Congestive
Pulmonary Artery Catheterization

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

ClinicalTrials.gov processed this record on August 30, 2016