Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

PHASE3CompletedINTERVENTIONAL
Enrollment

3,202

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
EmbolismThrombosis
Interventions
DRUG

Idrabiotaparinux sodium

"0.5 mL pre-filled syringe for 3.0 mg~Subcutaneous injection"

DRUG

Warfarin

"Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)~Oral administration"

DRUG

Placebo (for idrabiotaparinux sodium)

"0.5 mL pre-filled syringe~Subcutaneous injection"

DRUG

Avidin

"100 mg in 10 mg/mL solution~Intravenous infusion for 30 minutes"

DRUG

Placebo (for warfarin)

"Warfarin matching capsules~Oral administration"

DRUG

Enoxaparin

"Prefilled syringes as locally registered~Subcutaneous injection"

Trial Locations (38)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Buenos Aires

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park

Sanofi-Aventis Administrative Office, Vienna

Sanofi-Aventis Administrative Office, Minsk

Sanofi-Aventis Administrative Office, Diegem

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Sofia

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Santiago

Sanofi-Aventis Administrative Office, Shanghai

Sanofi-Aventis Administrative Office, Bogotá

Sanofi-Aventis Administrative Office, Zagreb

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Hørsholm

Sanofi-Aventis Administrative Office, Cairo

Sanofi-Aventis Administrative Office, Tallinn

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Athens

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Netanya

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Lysaker

Sanofi-Aventis Administrative Office, Lima

Sanofi-Aventis Administrative Office, Makati City

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administraive Office, San Juan

Sanofi-Aventis Admnistrative Office, Moscow

Sanofi-Aventis Administrative Office, Brastislava

Sanofi-Aventis Administrative Office, Midrand

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Bromma

Sanofi-Aventis Administrative Office, Istanbul

Sanofi-Aventis Administrative Office, Kiev

Sanofi-Aventis Administrative Office, Guildford Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY