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

Primary Purpose

Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carperitide
Placebo
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Drug

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in pulmonary capillary wedge pressure (PCWP)

Secondary Outcome Measures

Full Information

First Posted
November 28, 2005
Last Updated
November 4, 2016
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00259038
Brief Title
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
Official Title
A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction
Keywords
Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Drug
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Carperitide
Other Intervention Name(s)
human recombinant atrial natriuretic peptide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in pulmonary capillary wedge pressure (PCWP)
Time Frame
at 3 hours following initiation of study drug infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biljana Pavlovic-Surjancev, MD, PhD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
St Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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