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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00259038

Collaborator

(none)

162

Enrollment

Locations

Arms

Duration (Months)

4.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental Drug

Drug: Carperitide

Other Names:

human recombinant atrial natriuretic peptide

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline in pulmonary capillary wedge pressure (PCWP) [at 3 hours following initiation of study drug infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Huntsville	Alabama	United States	35801
2	Los Angeles	California	United States	90033
3	Orange	California	United States	92868
4	San Diego	California	United States	92103
5	Bay Pines	Florida	United States	33744
6	Gainesville	Florida	United States	32610
7	Jacksonville	Florida	United States	32216
8	Miami	Florida	United States	33136
9	Orlando	Florida	United States	32803
10	St Petersburg	Florida	United States	33707
11	Chicago	Illinois	United States	60611
12	Chicago	Illinois	United States	60612
13	Springfield	Illinois	United States	62701
14	Covington	Louisiana	United States	70433
15	Shreveport	Louisiana	United States	71103
16	Baltimore	Maryland	United States	21201
17	Minneapolis	Minnesota	United States	55455
18	St Louis	Missouri	United States	63110
19	Albany	New York	United States
20	Cincinnati	Ohio	United States	45267
21	Cleveland	Ohio	United States	44195
22	Tulsa	Oklahoma	United States
23	Charleston	South Carolina	United States
24	Columbia	South Carolina	United States
25	Amarillo	Texas	United States	79106
26	Houston	Texas	United States	77030
27	Houston	Texas	United States	77225
28	Richmond	Virginia	United States	23298
29	Tacoma	Washington	United States	98405
30	Madison	Wisconsin	United States	53792
31	Halifax	Nova Scotia	Canada	B3H 3A7
32	Toronto	Ontario	Canada	M5G 1X5
33	Montreal	Quebec	Canada
34	St Foy	Quebec	Canada	G1V 4G5