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

February 24, 2009 updated by: University Hospital, Strasbourg, France

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • BESANçON, France, 25000
        • Recruiting
        • Hôpital Saint-Jacques, CHU de Besançon
        • Sub-Investigator:
          • Emmanuel SAMAIN, MD
        • Contact:
        • Principal Investigator:
          • Myriam KRAUSZ-GRIGARD, MD
        • Sub-Investigator:
          • Ludovic VALENTIN, MD
      • Nancy, France, 54042
        • Recruiting
        • Maternité A. PINARD
        • Contact:
        • 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
      • Schiltigheim, France, 67303
        • Recruiting
        • Sihcus-Cmco
        • Contact:
        • Principal Investigator:
          • Rita VIZITIU, MD
        • Sub-Investigator:
          • Germain-Alain AISSI, MD
        • Sub-Investigator:
          • Danielle LE MAHO, MD
      • Strasbourg, France, 67098
        • Recruiting
        • Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Pierre Auguste DIEMUNSCH, MD
        • Sub-Investigator:
          • Bruno LANGER, MD
        • Sub-Investigator:
          • Israël NISAND, MD
        • Sub-Investigator:
          • Yves NOUDEM KANA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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
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

Outcome Measure
Time Frame
-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
During the first 48hour of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Pierre Auguste DIEMUNSCH, MD, Hopitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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