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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409253
First Posted: December 8, 2006
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  Purpose

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).

Condition Intervention Phase
Hypertension During Pre-Eclampsia Drug: URAPIDIL (EUPRESSYL*) Drug: NICARDIPINE Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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. [ Time Frame: 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 Measures:
  • -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 [ Time Frame: During the first 48hour of life ]

Estimated Enrollment: 72
Study Start Date: June 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Urapidil 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.
Active Comparator: Nicardipine 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409253


Contacts
Contact: Pierre Auguste DIEMUNSCH, MD 33.3.88.12.70.78 Pierre.Diemunsch@chru-strasbourg.fr

Locations
France
Hôpital Saint-Jacques, CHU de Besançon Recruiting
BESANçON, France, 25000
Contact: Myriam KRAUSZ-GRIGNARD, MD    33381219014    mgrignardkrausz@chu-besancon.fr   
Principal Investigator: Myriam KRAUSZ-GRIGARD, MD         
Sub-Investigator: Ludovic VALENTIN, MD         
Sub-Investigator: Emmanuel SAMAIN, MD         
Maternité A. PINARD Recruiting
Nancy, France, 54042
Contact: HERVE BOUAZIZ, MD    33383344490    h.bouaziz@chu-nancy.fr   
Principal Investigator: Hervé BOUAZIZ, MD         
Sub-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         
Sihcus-Cmco Recruiting
Schiltigheim, France, 67303
Contact: Rita VIZITIU, MD    33388628404    rita.vizitiu@chru-strasbourg.fr   
Principal Investigator: Rita VIZITIU, MD         
Sub-Investigator: Germain-Alain AISSI, MD         
Sub-Investigator: Danielle LE MAHO, MD         
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Pierre Auguste DIEMUNSCH, MD    33.3.88.12.70.78    Pierre.Diemunsch@chru-strasbourg.fr   
Principal Investigator: Pierre Auguste DIEMUNSCH, MD         
Sub-Investigator: Bruno LANGER, MD         
Sub-Investigator: Israël NISAND, MD         
Sub-Investigator: Yves NOUDEM KANA, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pierre Auguste DIEMUNSCH, MD Hôpitaux Universitaires de Strasbourg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00409253     History of Changes
Other Study ID Numbers: 3738
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France:
PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE

Additional relevant MeSH terms:
Hypertension
Eclampsia
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urapidil
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents