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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Dyspnea, Hypertension, Acute Heart Failure

In brief

The purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (AHF) patients receiving an intravenous (IV) infusion of clevidipine in comparison to standard of care (SOC) and placebo.

Key facts

Study ID

NCT04592380

Run by

The Medicines Company

People needed

0

Starts

2014-08-01

Expected to finish

2016-11-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older and providing
• Presentation consistent with AHF as manifest by pulmonary congestion
• Dyspnea score (sitting) ≥ 50 mm on a 100 mm visual analog scale
• In Stage 1, baseline SBP ≥130 - 160 mmHg (measured immediately prior to initiation of study drug); in Stage 2, baseline SBP ≥ 130 mmHg

You may not qualify if…

• Administration of an IV or oral antihypertensive agent within the previous 2 hours of randomization (short acting oral or sublingual nitrates are permitted)
• Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrome
• Known or suspected aortic dissection
• Acute myocardial infarction (AMI) within the prior 14 days
• Dialysis-dependent renal failure
• Requirement for immediate endotracheal intubation
• Suspected pregnancy or breast feeding female
• Intolerance or allergy to calcium channel blockers
• Allergy to soybean oil or lecithin
• Known liver failure, cirrhosis or pancreatitis
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

Where it is running

• Drug Research and Analysis Corporation/Jackson Hospital — Montgomery, Alabama, United States
• University of Arizona Medical Center — Tucson, Arizona, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Stony Brook University and Medical Center — Stony Brook, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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