NCT02558023

The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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))

Conditions

• Hypertension
• Preeclampsia

Interventions

Type	Name	Description
DRUG	Urapidil	Urapidil (Eupressyl\*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg. The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes. Maximum dose of 30 mg.h-1.
DRUG	Nicardipine	Nicardipine : IV 1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes. Maximum dose of 6 mg.h-1

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2015-09-23
• Last updated: 2020-08-25

Locations

2 sites across 1 country: France