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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Inc. |
United States, Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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