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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00409253
First received: December 7, 2006
Last updated: February 24, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 51 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 7, 2006
Last Updated: February 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 16, 2014