drugset / Trial / NCT00409253
Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nicardipine | Small molecule | 4 mg | Intravenous |
| Comparator | Urapidil | Small molecule | — | Intravenous |