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

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.

Condition	Intervention	Phase
Hypertension During Pre-Eclampsia	Drug: URAPIDIL (EUPRESSYL) Drug: Nicardipine (Loxen)	Phase III

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Nicardipine Nicardipine hydrochloride Urapidil

U.S. FDA Resources

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

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 24 hour of life [ Time Frame: During the first 24 hour of life ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (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 5 and 125 with adjustment 0.25 microg/kg/min/15 min
Nicardipine: Active Comparator	Drug: Nicardipine (Loxen) Nicardipine (Loxen) : 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
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
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	Not yet recruiting
	SCHILTIGHEIM, France, 67303
	Contact: Rita VIZITIU, MD 33388628404 rita.vizitiu@chru-strasbourg.fr
	Principal Investigator: Rita VIZITIU, MD
	Hôpital Jean Minjoz, CHU de Besançon	Not yet recruiting
	BESANçON, France, 25030
	Contact: Emmanuel SAMAIN, MD 33381668579 e1samain@chu-besancon.fr
	Principal Investigator: Emmanuel SAMAIN, MD
	Hôpital Saint-Jacques, CHU de Besançon	Not yet recruiting
	BESANçON, France, 25000
	Contact: Myriam KRAUSZ-GRIGNARD, MD 33381219014 mgrignardkrausz@chu-besancon.fr
	Principal Investigator: Myriam KRAUSZ-GRIGARD, MD
	Maternité A. PINARD	Not yet recruiting
	NANCY, France, 54042
	Contact: HERVE BOUAZIZ, MD 33383344490 h.bouaziz@chu-nancy.fr
	Principal Investigator: Hervé BOUAZIZ, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators


Principal Investigator:	Pierre Auguste DIEMUNSCH, MD	Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers:	3738
First Received:	December 7, 2006
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00409253
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:

Hypertension, Pregnancy-Induced

Pregnancy Complications

Eclampsia

Vascular Diseases

Pregnancy toxemia /hypertension

Pre-Eclampsia

Nicardipine

Preeclampsia

Serotonin

Urapidil

Hypertension

Additional relevant MeSH terms:

Serotonin Agonists

Vasodilator Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Physiological Effects of Drugs

Calcium Channel Blockers

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Pharmacologic Actions

Membrane Transport Modulators

Serotonin Agents

Therapeutic Uses

Cardiovascular Diseases

Adrenergic Antagonists

ClinicalTrials.gov processed this record on October 22, 2008

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