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

Primary Purpose

Hypertension During Pre-Eclampsia

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

URAPIDIL (EUPRESSYL*)

NICARDIPINE

About this trial

This is an interventional treatment trial for Hypertension During Pre-Eclampsia focused on measuring PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Saint-Jacques, CHU de BesançonRecruiting
Maternité A. PINARDRecruiting
Sihcus-CmcoRecruiting
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Urapidil

Nicardipine

Arm Description

Outcomes

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.

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

Full Information

NCT ID

NCT00409253

First Posted

December 7, 2006

Last Updated

February 24, 2009

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00409253

Brief Title

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

Official Title

Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2007 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension During Pre-Eclampsia

Keywords

PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Urapidil

Arm Type

Active Comparator

Arm Title

Nicardipine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

URAPIDIL (EUPRESSYL*)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

NICARDIPINE

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

Secondary Outcome Measure Information:

Title

-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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

51 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Auguste DIEMUNSCH, MD

Phone

33.3.88.12.70.78

Pierre.Diemunsch@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Auguste DIEMUNSCH, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Saint-Jacques, CHU de Besançon

City

BESANçON

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Myriam KRAUSZ-GRIGNARD, MD

Phone

33381219014

mgrignardkrausz@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Myriam KRAUSZ-GRIGARD, MD

First Name & Middle Initial & Last Name & Degree

Ludovic VALENTIN, MD

First Name & Middle Initial & Last Name & Degree

Emmanuel SAMAIN, MD

Facility Name

Maternité A. PINARD

City

Nancy

ZIP/Postal Code

54042

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HERVE BOUAZIZ, MD

Phone

33383344490

h.bouaziz@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Hervé BOUAZIZ, MD

First Name & Middle Initial & Last Name & Degree

Eric SAVOYE, MD

First Name & Middle Initial & Last Name & Degree

Yves CHALOT, MD

First Name & Middle Initial & Last Name & Degree

Nour-Eddine BAKA, MD

First Name & Middle Initial & Last Name & Degree

Sylvie BOILEAU, MD

First Name & Middle Initial & Last Name & Degree

Florence VIAL, MD

First Name & Middle Initial & Last Name & Degree

Philippe JUDLIN, MD

First Name & Middle Initial & Last Name & Degree

Olivier THIEBAUGEORGES, MD

First Name & Middle Initial & Last Name & Degree

Amandine BARBIER-LEREBOURS, MD

Facility Name

Sihcus-Cmco

City

Schiltigheim

ZIP/Postal Code

67303

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rita VIZITIU, MD

Phone

33388628404

rita.vizitiu@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Rita VIZITIU, MD

First Name & Middle Initial & Last Name & Degree

Germain-Alain AISSI, MD

First Name & Middle Initial & Last Name & Degree

Danielle LE MAHO, MD

Facility Name

Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Auguste DIEMUNSCH, MD

Phone

33.3.88.12.70.78

Pierre.Diemunsch@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Pierre Auguste DIEMUNSCH, MD

First Name & Middle Initial & Last Name & Degree

Bruno LANGER, MD

First Name & Middle Initial & Last Name & Degree

Israël NISAND, MD

First Name & Middle Initial & Last Name & Degree

Yves NOUDEM KANA, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26148170

Citation

Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.

Results Reference

derived

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

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