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Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia

NCT00198588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2008-11-13

No results posted yet for this study

Summary

The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The reason of the lower initial dose is that the approved dose of argatroban in Japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aPTT, and blood drug concentration.

Conditions

  • Heparin-Induced Thrombocytopenia

Interventions

DRUG

argatroban

beginning dose: 0.7microgram/kg/H

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    collaborator INDUSTRY

  • Ministry of Health, Labour and Welfare, Japan

    lead OTHER_GOV

Principal Investigators

  • Hitonobu TOMOIKE, MD, PhD · National Cerebral and Cardiovascular Center, Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-07-31
Completion
2006-09-30

Countries

  • Japan

Study Locations

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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 NCT00198588 on ClinicalTrials.gov