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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00259038
Enrollment
162
Registered
2005-11-29
Start date
2004-01-31
Completion date
2006-02-28
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Decompensation, Heart Failure, Congestive, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction

Keywords

Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization

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.

Interventions

DRUGCarperitide
DRUGPlacebo

Sponsors

Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026