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

• Status: Unknown status
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Nicardipine; Urapidil

Criteria

Inclusion criteria:

• patients 'written informed consent dated and signed by investigator and patient

• affiliation to a social security system

• single pregnancy

• arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe pre-eclampsia

Exclusion criteria:

• patient under 18 year old or unable to give informed consent

• protocol rejected by patient-impossibility to use non invasive blood pressure monitoring

• antihypertensive treatments within 24h before inclusion

• allergy to or contraindication for one of the study drugs-pre

• eclampsia that does not require an antihypertensive treatment

• acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs

• participation to a therapeutic protocol within 6 months prior to the start of study