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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: November 28, 2005
Last updated: November 4, 2016
Last verified: November 2016
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
Systolic or Diastolic Left Ventricular Dysfunction
Drug: Carperitide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change from baseline in pulmonary capillary wedge pressure (PCWP) [ Time Frame: at 3 hours following initiation of study drug infusion ]

Enrollment: 162
Study Start Date: January 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug Drug: Carperitide
Other Name: human recombinant atrial natriuretic peptide
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is hospitalized with congestive heart failure (CHF)
  • Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

Exclusion Criteria:

  • Has had a heart transplant
  • Requires mechanical ventilation or mechanical circulatory support
  Contacts and Locations
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Please refer to this study by its identifier: NCT00259038

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

Responsible Party: Daiichi Sankyo Inc. Identifier: NCT00259038     History of Changes
Other Study ID Numbers: 03-0-162
Study First Received: November 28, 2005
Last Updated: November 4, 2016

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

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017