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


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting Hypertension During Pre-Eclampsia University Hospital, Strasbourg, France Other December 7, 2006 February 24, 2009 February 2009

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment Phase 3 72 June 2007 -

Locations

FacilityAddressContactPhoneEmailStatus
Hôpital Saint-Jacques, CHU de Besançon BESANçON 25000 France Myriam KRAUSZ-GRIGNARD, MD - mgrignardkrausz@chu-besancon.fr Recruiting
Maternité A. PINARD Nancy 54042 France HERVE BOUAZIZ, MD - h.bouaziz@chu-nancy.fr Recruiting
Sihcus-Cmco Schiltigheim 67303 France Rita VIZITIU, MD - rita.vizitiu@chru-strasbourg.fr Recruiting
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Strasbourg 67098 France Pierre Auguste DIEMUNSCH, MD - Pierre.Diemunsch@chru-strasbourg.fr Recruiting

Intervention

TypeInterventionDescription
Drug URAPIDIL (EUPRESSYL*) Urapidil (Eupressyl*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
Drug NICARDIPINE Nicardipine : IV 6.25 mg bolus until PAD >105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days

Outcome

TypeMeasureTime FrameSafety Issue
Primary 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. 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 Yes
Secondary -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 During the first 48hour of life Yes

Official Title

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

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Female - 51 Years No

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