Viewing Study NCT00182403


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Study NCT ID: NCT00182403
Status: COMPLETED
Last Update Posted: 2017-06-07
First Post: 2005-09-13
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Fixed Dose Heparin Study
Sponsor: McMaster University
Organization:

Study Overview

Official Title: Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism
Status: COMPLETED
Status Verified Date: 2017-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).
Detailed Description: The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
#NA3640 None None View