The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.
The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. Secondary objectives included assessments of efficacy through measuring time to target blood pressure (BP) lowering effect defined as 15% reduction in SBP, change in mean arterial pressure (MAP) and the incidence of bailout by causality. Assessments for safety included change in heart rate (HR) from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
206
Discovery Alliance - Mobile Infirmary Medical Center
Mobile, Alabama, United States
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Incidence of bailout during 30-minute treatment period
The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons: * Bailout for lack of efficacy * Bailout for safety reason(s) * Bailout due to treatment failure
Time frame: During the first 30 minutes post study drug initiation
Median time to target SBP lowering effect (defined as a reduction by 15% or more)
Time frame: During the first 30 minutes post study drug initiation
Mean arterial pressure (MAP) change from baseline
Time frame: During the first 30 minutes post study drug initiation
Heart rate change from baseline
Time frame: During the first 30 minutes post study drug initiation
Incidence of bailout by causality
Time frame: During the first 30 minutes post study drug initiation
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