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

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00409253

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Urapidil Nicardipine hydrochloride Nicardipine

U.S. FDA Resources

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
Urapidil: Active Comparator	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.
Nicardipine: Active Comparator	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

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
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
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
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

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:	Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg ( Christine GEILLER )
Study ID Numbers:	3738
Study First Received:	December 7, 2006
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00409253 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Vasodilator Agents
Pregnancy Complications
Adrenergic Agents
Eclampsia
Vascular Diseases
Pre-Eclampsia
Calcium Channel Blockers
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Preeclampsia
Serotonin
Urapidil
Calcium, Dietary
Hypertension, Pregnancy-Induced
Adrenergic Antagonists
Nicardipine
Hypertension

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Vasodilator Agents
Pregnancy Complications
Adrenergic Agents
Eclampsia
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Pre-Eclampsia
Calcium Channel Blockers
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Urapidil
Membrane Transport Modulators
Hypertension, Pregnancy-Induced
Serotonin Agents
Therapeutic Uses
Adrenergic Antagonists
Cardiovascular Diseases
Nicardipine
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009