NCT00409253

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

December 7, 2006

Last Update Submit

February 24, 2009

Conditions

Hypertension During Pre-Eclampsia

Keywords

PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • -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

    During the first 48hour of life

Study Arms (2)

Urapidil

ACTIVE COMPARATOR
Drug: URAPIDIL (EUPRESSYL*)

Nicardipine

ACTIVE COMPARATOR
Drug: NICARDIPINE

Interventions

URAPIDIL (EUPRESSYL*)DRUG

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.

Urapidil
NICARDIPINEDRUG

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

Nicardipine

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Saint-Jacques, CHU de Besançon

Besançon, 25000, France

RECRUITING

Maternité A. PINARD

Nancy, 54042, France

RECRUITING

Sihcus-Cmco

Schiltigheim, 67303, France

RECRUITING

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

Strasbourg, 67098, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26148170DERIVED

MeSH Terms

Interventions

urapidilNicardipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pierre Auguste DIEMUNSCH, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Auguste DIEMUNSCH, MD

CONTACT

33.3.88.12.70.78Pierre.Diemunsch@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

June 1, 2007

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

FR(4)