Start Date
August 31, 2014
Primary Completion Date
February 29, 2016
Study Completion Date
November 30, 2016
Stage 1: Clevidipine (double-blinded)
Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Stage 1: Placebo (double-blinded)
Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded placebo infusion, an oral antihypertensive agent may be administered. The placebo infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Stage 2: Clevidipine (open-label)
Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
Stage 2: Standard of Care (open-label)
Transition to oral antihypertensive medication from SOC IV antihypertensive is per institutional practice.
New York Methodist Hospital, Brooklyn
Maimonides Medical Center, Brooklyn
Stony Brook University and Medical Center, Stony Brook
Duke University Hospital, Durham
Drug Research and Analysis Corporation/Jackson Hospital, Montgomery
University of Cincinnati, Cincinnati
Washington University School of Medicine, St Louis
Baylor College of Medicine, Houston
University of Arizona Medical Center, Tucson
Lead Sponsor
The Medicines Company
INDUSTRY