Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2014

Primary Completion Date

February 29, 2016

Study Completion Date

November 30, 2016

Conditions
DyspneaHypertensionAcute Heart Failure
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Stage 2: Standard of Care (open-label)

Transition to oral antihypertensive medication from SOC IV antihypertensive is per institutional practice.

Trial Locations (9)

11215

New York Methodist Hospital, Brooklyn

11219

Maimonides Medical Center, Brooklyn

11794

Stony Brook University and Medical Center, Stony Brook

27710

Duke University Hospital, Durham

36106

Drug Research and Analysis Corporation/Jackson Hospital, Montgomery

45267

University of Cincinnati, Cincinnati

63110

Washington University School of Medicine, St Louis

77030

Baylor College of Medicine, Houston

85719

University of Arizona Medical Center, Tucson

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY

NCT04592380 - Clevidipine vs Placebo or Standard of Care for Dyspnea and Blood Pressure Control in AHF | Biotech Hunter | Biotech Hunter