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: 33.3.88.12.70.78, Email: Pierre.Diemunsch@chru-strasbourg.fr
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).
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
Eligibility
Minimum age: 18 Years.
Maximum age: 51 Years.
Gender(s): Female.
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
Locations and Contacts
Pierre Auguste DIEMUNSCH, MD, Phone: 33.3.88.12.70.78, 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: 33.3.88.12.70.78, 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
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