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NCT00259038 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259038
Other study ID # 03-0-162
Secondary ID
Status Completed
Phase Phase 2
First received November 28, 2005
Last updated November 4, 2016
Start date January 2004
Est. completion date February 2006

Study information
Verified date November 2016
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Carperitide

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in pulmonary capillary wedge pressure (PCWP) at 3 hours following initiation of study drug infusion No
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