Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Heart Defects, Congenital
Interventions
DRUG

Clopidogrel

"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 (15)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Budapest

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Kuala Lumpur

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Porto Salvo

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Taipei

Sanofi-Aventis Administrative Office, Guildford Surrey

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Sanofi

INDUSTRY