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

Phase 3

• Conditions: Hypertension During Pre-Eclampsia
• Interventions: Drug: URAPIDIL (EUPRESSYL*); Drug: NICARDIPINE

• Registration Number: NCT00409253
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Study Start: 2007-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-24
• Last Update Posted: 2009-02-25
• Primary Completion: 2010-06
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urapidil	URAPIDIL (EUPRESSYL*)	-
Nicardipine	NICARDIPINE	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
-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

Trial Locations

Locations (4)

Hôpital Saint-Jacques, CHU de Besançon; 🇫🇷 BESANçON, France

Sihcus-Cmco; 🇫🇷 Schiltigheim, France

Maternité A. PINARD; 🇫🇷 Nancy, France

Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France