drugset / Trial / NCT00409253

Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

NCT00409253

Phase 3 Unknown 72 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients. * efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration. * safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

Timeline

Start
2007-06
Primary completion
2010-06
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicardipine Small molecule 4 mg Intravenous
Comparator Urapidil Small molecule Intravenous

Indications