105
Participants
Start Date
January 31, 2004
Primary Completion Date
November 30, 2004
Study Completion Date
November 30, 2004
clevidipine
Clevidipine (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
placebo
Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.
Wake Forest University School of Medicine, Winston-Salem
Atlanta VA Medical Center, Atlanta
Discovery Alliance - Sacred Heart Hospital, Pensacola
Discovery Alliance - Hudson, Hudson
Cardio-Thoracic Surgeons, PC, Birmingham
The Christ Hospital, The Linder Clinical Trial Center, Cincinnati
MacNeal Hospital, Berwyn
Memorial Herman Memorial City Hospital, Houston
Texas Heart Institute, Houston
Houston Northwest Medical Center, Houston
St Vincent Medical Center, Los Angeles
Swedish Hospital Medical Center, Seattle
Lead Sponsor
The Medicines Company
INDUSTRY