A Phase 3 interventional study of clevidipine and nitroglycerin in Hypertension, sponsored by The Medicines Company. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-06.
Sponsored by The Medicines Company · Phase 3, Interventional, and Treatment
The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative 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 nitroglycerin.
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 629 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →The Medicines Company is the lead sponsor of 48 studies on the registry; none are open to participants now.
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Prerandomization Inclusion Criteria:
Prerandomization Exclusion Criteria:
Postrandomization Inclusion Criteria:
Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours.
Drug: clevidipine
Nitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.
Drug: nitroglycerin
Also known as: clevidipine, Cleviprex
Incidence of death, stroke, MI and renal dysfunction
Time frame: Initiation of study drug infusion through post-operative Day 30
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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