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

Information source: University Hospital, Strasbourg, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension During Pre-Eclampsia

Intervention: URAPIDIL (EUPRESSYL*) (Drug); NICARDIPINE (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Strasbourg, France

Official(s) and/or principal investigator(s):
Pierre Auguste DIEMUNSCH, MD, Principal Investigator, Affiliation: Hôpitaux Universitaires de Strasbourg

Overall contact:
Pierre Auguste DIEMUNSCH, MD, Phone:, Email: Pierre.Diemunsch@chru-strasbourg.fr


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).

Clinical Details

Official title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period.

Secondary outcome: -maternal and foetal ultrasonography, biology and clinical assessment-type of delivery-post-partum bleeding-neo-natal evaluation by neonatologist during the first 48 hours of life


Minimum age: 18 Years. Maximum age: 51 Years. Gender(s): Female.


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


- 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

Locations and Contacts

Pierre Auguste DIEMUNSCH, MD, Phone:, Email: Pierre.Diemunsch@chru-strasbourg.fr

Hôpital Saint-Jacques, CHU de Besançon, BESANçON 25000, France; Recruiting
Myriam KRAUSZ-GRIGNARD, MD, Phone: 33381219014, Email: mgrignardkrausz@chu-besancon.fr
Myriam KRAUSZ-GRIGARD, MD, Principal Investigator
Ludovic VALENTIN, MD, Sub-Investigator
Emmanuel SAMAIN, MD, Sub-Investigator

Maternité A. PINARD, Nancy 54042, France; Recruiting
HERVE BOUAZIZ, MD, Phone: 33383344490, Email: h.bouaziz@chu-nancy.fr
Hervé BOUAZIZ, MD, Principal Investigator
Eric SAVOYE, MD, Sub-Investigator
Yves CHALOT, MD, Sub-Investigator
Nour-Eddine BAKA, MD, Sub-Investigator
Sylvie BOILEAU, MD, Sub-Investigator
Florence VIAL, MD, Sub-Investigator
Philippe JUDLIN, MD, Sub-Investigator
Olivier THIEBAUGEORGES, MD, Sub-Investigator
Amandine BARBIER-LEREBOURS, MD, Sub-Investigator

Sihcus-Cmco, Schiltigheim 67303, France; Recruiting
Rita VIZITIU, MD, Phone: 33388628404, Email: rita.vizitiu@chru-strasbourg.fr
Rita VIZITIU, MD, Principal Investigator
Germain-Alain AISSI, MD, Sub-Investigator
Danielle LE MAHO, MD, Sub-Investigator

Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg 67098, France; Recruiting
Pierre Auguste DIEMUNSCH, MD, Phone:, Email: Pierre.Diemunsch@chru-strasbourg.fr
Pierre Auguste DIEMUNSCH, MD, Principal Investigator
Bruno LANGER, MD, Sub-Investigator
Israël NISAND, MD, Sub-Investigator
Yves NOUDEM KANA, MD, Sub-Investigator

Additional Information

Starting date: June 2007
Last updated: February 24, 2009

Page last updated: August 23, 2015

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