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

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Clevidipine; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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