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

University Hospital, Strasbourg, France

Status and phase

Unknown

Phase 3

Conditions

Hypertension During Pre-Eclampsia

Treatments

Drug: NICARDIPINE

Drug: URAPIDIL (EUPRESSYL*)

Study type

Interventional

Funder types

Other

Identifiers

NCT00409253

3738

Details and patient eligibility

About

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).

Enrollment

72 estimated patients

Sex

Female

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

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