Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation

PHASE3CompletedINTERVENTIONAL
Enrollment

906

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Heart Defects, Congenital
Interventions
DRUG

Clopidogrel (SR25990)

"Form: reconstituted solution using Clopidogrel powder~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"

DRUG

placebo

"Form: reconstituted solution using matching placebo powder~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"

Trial Locations (31)

94609

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Buenos Aires

Sanofi-Aventis Administrative Office, Diegem

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Shangaï

Sanofi-Aventis Administrative Office, Hørsholm

Sanofi-Aventis Administrative Office, Cairo

Sanofi-Aventis Administrative Office, Helsinki

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Causeway Bay

Sanofi-Aventis Administrative Office, Budapest

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Netanya

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Kuala Lumpur

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, Gouda

Sanofi-Aventis Administrative Office, Lysaker

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Singapore

Sanofi-Aventis Administrative Office, Midrand

Sanofi-Aventis Administrative Office, Seoul

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Bromma

Sanofi-Aventis Administrative Office, Taipei

Sanofi-Aventis Administraive Office, Bangkok

Sanofi-Aventis Admnistrative Office, Guildford Surrey

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Sanofi

INDUSTRY