Acute hypertension in patients who present with intracerebral hemorrhage MedDRA version: 9.1 Level: LLT Classification code 10022754 Term: Intracerebral hemorrhage 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
INN or Proposed INN: Clevidipine
CAS Number: 167221-71-8
Current Sponsor code: Clevidipine
Conce
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CT evidence of intracerebral hemorrhage (diagnosis within 6 hours of symptom onset) 2. Age 18 years or older 3. Baseline systolic blood pressure (SBP) (immediately prior initiation of clevidipine) > 160 mm Hg measured using an arterial line 4. Requires antihypertensive therapy to achieve SBP less than or equal to 160 mm HG 5. Written informed consent from the patient or their legal representative 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. Decision for early surgical evacuation (e.g. large cerebellar or lobar hemorrhage) 2. Receipt of an oral hypertensive within 2 hours prior to initiation of clevidipine 3. Treatment with a continuous infusion of an intravenous (IV) antihypertensive agent prior to initiation of clevidipine. Bolus treatment with labetalol or hydralazine is permitted 4. Intracerebral hematoma considered to be related to trauma by neurologist or neurosurgeon 5. Aneurysmal sub-arachnoid hemorrhage 6. Glasgow coma score 1.3 at screening) 9. Known or suspected aortic dissection 10. Acute myocardial infarction (AMI) 11. Positive pregnancy test or known pregnancy 12. Intolerance or allergy to calcium channel blockers 13. Allergy to soybean oil or egg lecithin 14. Known liver failure, cirrhosis or pancreatitis 15. Prior directives against advanced life support 16. 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 of a titration dosing regimen of an intravenous infusion of clevidipine for the treatment of acute hypertension in patients with intracerebral hemorrhage ;Secondary Objective: The secondary objectives of the study include evaluating the percentage of patients who reach the target SBP within 30 minutes of the initiation of clevidipine infusion and percent change from baseline in SBP. Blood pressure management, the magnitude, frequency and duration of SBP excursion outside the target range and the percent time blood pressures were maintained within the target range during clevidipine infusion will be determined. The need for an alternative antihypertensive agent to maintain BP within the target range and the mean and median dose of clevidipine during the treatment period will be evaluated. The safety of a prolonged infusion of clevidipine based on clinical and laboratory assessments and AEs will be evaluated. Several exploratory analyses are planned which include evaluating the change in hematoma volumes, measuring perihematoma edema, assessment of neurological function following clevidipine infusion and explore BP control using wider ranges.;Primary end point(s): The median time to achieve the target blood pressure (Systolic Blood Pressure less than or equal to 160 mm Hg to greater than or equal to 140 mmHg) within 30 minutes of initiation of the clevidipine infusion. | — |
Countries
Germany
Outcome results
None listed