acute heart failure and elevated BP (systolic blood pressure [SBP] =160 mm Hg) requiring parenteral IV antihypertensive therapy MedDRA version: 9.1 Level: LLT Classification code 10000803 Term: Acute heart failure MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: Clevidipine butyrate
Product Code: Clevidipine
Pharmaceutical Form: Emulsion for infusion
CAS Number: 167221-71-8
Current Sponsor code: Clevidipine
Concentration unit: mg/ml milligram(s)
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Presentation consistent with AHF and pulmonary congestion on physical examination as evidenced by rales. 3. Baseline SBP (immediately prior to initiation of study drug) of =160 mm Hg 4. Dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (VAS) 5. Requires IV antihypertensive therapy to lower BP 6. Written informed consent before initiation of any study related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Administration of an agent (IV or oral) for the treatment of elevated BP within the previous 2 hours of randomization. (Previous short acting non- IV nitrates, CPAP and BiPAP are permitted) 2. Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrom. 3. Known or suspected aortic dissection 4. Acute Myocardial Infarction (AMI) within the prior 14 days 5. Dialysis dependant renal failure 6. Requirement for immediate endotracheal intubation 7. Positive pregnancy test, known pregnancy or breast feeding female 8. Intolerance or allergy to calcium channel blockers 9. Allergy to soybean oil or egg lecithin 10. Known liver failure, cirrhosis or pancreatitis 11. Prior directives against advanced life support (no code status) 12. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of an intravenous (IV) infusion of clevidipine as compared with standard of care (SOC) IV antihypertensive for blood pressure (BP) lowering in patients with acute heart failure (AHF) and elevated BP. ;Secondary Objective: Exploratory objectives are to evaluate the effects on fluid balance, diuretic use and renal function and the evaluation of health economic parameters and resource utilization with clevidipine as compared to SOC IV antihypertensive treatment. ;Primary end point(s): Median time and percent of patients that attain the initial prespecified systolic blood pressure (SBP) target range (minimum of 20 mm Hg and a maximum of 40 mm Hg apart) and a 15% reduction in SBP from baseline within the first 30 minutes | — |
Countries
Germany
Outcome results
None listed