The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
Status:
Terminated
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to demonstrate that urapidil is not inferior to nicardipine
for the treatment of hypertension associated with preeclampsia (PE) and that it is better
tolerated.
- efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min
of study drug administration.
- safety endpoints : clinical and biological observation for any side effect. All infants
will be observed in the neonatology unit (during 48h).
Pharmacokinetic study included to study :
- transplacental transfer,
- transfer in breast milk,
- and neonatal elimination (premature babies of mothers treated with urapidil (less than
33 WG))