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

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ClinicalTrials.gov Identifier: NCT00259038
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Heart Decompensation Left Ventricular Failure Myocardiopathies Systolic or Diastolic Left Ventricular Dysfunction Drug: Carperitide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2004
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Drug Drug: Carperitide
Other Name: human recombinant atrial natriuretic peptide
Placebo Comparator: Placebo Drug: Placebo



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


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

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

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): NCT00259038


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

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00259038     History of Changes
Other Study ID Numbers: 03-0-162
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

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