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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)
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.
Details
| Lead sponsor | The Medicines Company |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2014-08 |
| Completion | 2016-11 |
Conditions
- Dyspnea
- Hypertension
- Acute Heart Failure
Interventions
- Stage 1: Clevidipine (double-blinded)
- Stage 1: Placebo (double-blinded)
- Stage 2: Clevidipine (open-label)
- Stage 2: Standard of Care (open-label)
Primary outcomes
- Change in dyspnea VAS score from baseline at 3 hours post-baseline — Immediately prior to study drug administration (baseline) to 3 hours post-baseline
Countries
United States