218
Participants
Start Date
May 31, 2006
Primary Completion Date
April 30, 2008
Study Completion Date
March 31, 2010
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
"Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.~Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
"Aflibercept 2.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks.~Aflibercept could be reduced by 1 dose level (to 1.0 mg/kg) or 2 dose levels (to 0.5 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment."
Sanofi-Aventis Administrative Office, Bridgewater
Sanofi-Aventis Administrative Office, Macquarie Park
Sanofi-Aventis Administrative Office, Laval
Sanofi-Aventis Administrative Office, Paris
Sanofi-Aventis Administrative Office, Berlin
Sanofi-Aventis Administrative Office, Milan
Sanofi-Aventis Administrative Office, Gouda
Sanofi-Aventis Administrative Office, Porto Salvo
Sanofi-Aventis Administrative Office, Barcelona
Sanofi-Aventis Administrative Office, Bromma
Sanofi-Aventis Administrative Office, Geneva
Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY