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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2005

Last Updated Date

August 29, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00259038 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Heart Failure, Congestive
Heart Decompensation
Left Ventricular Failure
Myocardiopathies
Systolic or Diastolic Left Ventricular Dysfunction

Intervention ^ICMJE

Drug: Carperitide (human recombinant atrial natriuretic peptide)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00259038

Other Study ID Numbers ^ICMJE

03-0-162

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma US, Inc.

Investigators ^ICMJE

Study Director:

Biljana Pavlovic-Surjancev, MD, PhD

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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