Status:
UNKNOWN
Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Hypertension During Pre-Eclampsia
Eligibility:
FEMALE
18-51 years
Phase:
PHASE3
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 pressu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00409253
Start Date
June 1 2007
End Date
August 1 2010
Last Update
February 25 2009
Active Locations (4)
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1
Hôpital Saint-Jacques, CHU de Besançon
Besançon, France, 25000
2
Maternité A. PINARD
Nancy, France, 54042
3
Sihcus-Cmco
Schiltigheim, France, 67303
4
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098