Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

November 30, 2004

Study Completion Date

November 30, 2004

Conditions
Hypertension
Interventions
DRUG

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.

DRUG

placebo

Placebo (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.

Trial Locations (12)

27157

Wake Forest University School of Medicine, Winston-Salem

30322

Atlanta VA Medical Center, Atlanta

32503

Discovery Alliance - Sacred Heart Hospital, Pensacola

34667

Discovery Alliance - Hudson, Hudson

35213

Cardio-Thoracic Surgeons, PC, Birmingham

45219

The Christ Hospital, The Linder Clinical Trial Center, Cincinnati

60402

MacNeal Hospital, Berwyn

77024

Memorial Herman Memorial City Hospital, Houston

77030

Texas Heart Institute, Houston

77090

Houston Northwest Medical Center, Houston

90057

St Vincent Medical Center, Los Angeles

98104-1318

Swedish Hospital Medical Center, Seattle

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY