drugset / Trial / NCT03300479

Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)

NCT03300479

Phase 4 Withdrawn University of Zurich
RandomizedParallel-groupOpen-labelTreatment

Summary

Intracerebral hemorrhage (ICH) is responsible for 10-15% of primary strokes. ICH is a dynamic process with three phases: initial hemorrhage, followed by hematoma expansion and perihematoma edema formation. Hematoma volume is correlated with disease progression and outcome. Contemporary evidence proposes that elevated blood pressure is associated with hematoma expansion while more than 90% of patients with ICH present with acute hypertension. Uncontrolled blood pressure is a leading cause of ICH and it seems also to be a factor of poorer outcomes. Therefore, rapid reduction and control of blood pressure might ease disease progression and improve the outcome. Clevidipine (Cleviprex®), an ultrashort-acting dihydropyridine calcium channel antagonist, with its rapid onset and short duration might be more effective than conventional antihypertensives to achieve rapid blood pressure control in patients with acute ICH.

Timeline

Start
2017-06-15
Primary completion
2021-05-14
Completion
2021-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevidipine Small molecule 2 mg Intravenous
Subject Clevidipine Small molecule 16 mg Intravenous
Comparator Urapidil Small molecule 5 mg Intravenous
Comparator Urapidil Small molecule 40 mg Intravenous