42
Participants
Start Date
March 31, 2009
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
AIN457
The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.
Placebo
Matching placebo to AIN457
Novartis Investigative Site, Amsterdamn
Novartis Investigative Site, Meerssen
Novartis Investigative Site, Berlin
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Herne
Novartis Investigative Site, München
Novartis Investigative Site, Glasgow
Novartis Investigative Site, Leeds
Novartis Investigative Site, Newcastle upon Tyne
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY