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

Hypertension Clinical Trial

Official title: A Randomized Parallel Group Controlled Comparison Study of Clevidipine Versus Placebo or Standard of Care for Dyspnea and Blood Pressure Control in Acute Heart Failure (PRONTO II)

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Randomization will occur in two stages. Stage 1 patients will be randomized in a double-blinded manner in a 1:1 ratio to receive either clevidipine or placebo IV infusion. Upon completion of Stage 1, Stage 2 patients will be randomized in an open-label manner in a 1:1 ratio to receive either clevidipine or standard of care (SOC) IV infusion. At the time of randomization, a patient-specific, prespecified systolic blood pressure (SBP) target range will be determined and recorded prior to study drug treatment. Up to 500 patients may be enrolled to achieve a total of 100 Stage 1 and 300 Stage 2 patients with confirmed AHF per protocol. A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor the safety of patients. Adverse events will be assessed for 7 days post-study randomization or hospital discharge, whichever occurred sooner. Serious adverse events (SAEs) were assessed for 30 days following study randomization. ;

Related Conditions & MeSH terms

• Acute Heart Failure
• Dyspnea
• Heart Failure
• Hypertension

• NCT number: NCT04592380
• Study type: Interventional
• Source: The Medicines Company
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2014
• Completion date: November 2016