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Study Of Angiomax In Infants Under Six Months With Thrombosis

NCT00043277 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2006-02-01

No results posted yet for this study

Summary

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;
2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;
3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Conditions

Interventions

DRUG

Angiomax (bivalirudin)

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Guy Young, MD · Children's Hospital Orange County

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Completion
2004-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00043277 on ClinicalTrials.gov