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

November 4, 2016 updated by: Daiichi Sankyo, Inc.

A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
    • Quebec
      • Montreal, Quebec, Canada
      • St Foy, Quebec, Canada, G1V 4G5
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • California
      • Los Angeles, California, United States, 90033
      • Orange, California, United States, 92868
      • San Diego, California, United States, 92103
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33136
      • Orlando, Florida, United States, 32803
      • St Petersburg, Florida, United States, 33707
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
      • Springfield, Illinois, United States, 62701
    • Louisiana
      • Covington, Louisiana, United States, 70433
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • St Louis, Missouri, United States, 63110
    • New York
      • Albany, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44195
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Texas
      • Amarillo, Texas, United States, 79106
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77225
    • Virginia
      • Richmond, Virginia, United States, 23298
    • Washington
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Experimental Drug
Drug: Carperitide
Other Names:
  • human recombinant atrial natriuretic peptide

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Investigators

  • Study Director: Biljana Pavlovic-Surjancev, MD, PhD, Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-0-162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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