Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Strasbourg, France
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00409253
First received: December 7, 2006
Last updated: February 24, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension During Pre-Eclampsia |
Drug: URAPIDIL (EUPRESSYL*) Drug: NICARDIPINE |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE |
Resource links provided by NLM:
Further study details as provided by University Hospital, Strasbourg, France:
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. [ 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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: During the first 48hour of life ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 51 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409253
Contacts
| Contact: Pierre Auguste DIEMUNSCH, MD | 33.3.88.12.70.78 | Pierre.Diemunsch@chru-strasbourg.fr |
Locations
| France | |
| Hôpital Saint-Jacques, CHU de Besançon | Recruiting |
| BESANçON, France, 25000 | |
| Contact: Myriam KRAUSZ-GRIGNARD, MD 33381219014 mgrignardkrausz@chu-besancon.fr | |
| Principal Investigator: Myriam KRAUSZ-GRIGARD, MD | |
| Sub-Investigator: Ludovic VALENTIN, MD | |
| Sub-Investigator: Emmanuel SAMAIN, MD | |
| Maternité A. PINARD | Recruiting |
| Nancy, France, 54042 | |
| Contact: HERVE BOUAZIZ, MD 33383344490 h.bouaziz@chu-nancy.fr | |
| 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 | |
| Sihcus-Cmco | Recruiting |
| Schiltigheim, France, 67303 | |
| Contact: Rita VIZITIU, MD 33388628404 rita.vizitiu@chru-strasbourg.fr | |
| Principal Investigator: Rita VIZITIU, MD | |
| Sub-Investigator: Germain-Alain AISSI, MD | |
| Sub-Investigator: Danielle LE MAHO, MD | |
| Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: Pierre Auguste DIEMUNSCH, MD 33.3.88.12.70.78 Pierre.Diemunsch@chru-strasbourg.fr | |
| Principal Investigator: Pierre Auguste DIEMUNSCH, MD | |
| Sub-Investigator: Bruno LANGER, MD | |
| Sub-Investigator: Israël NISAND, MD | |
| Sub-Investigator: Yves NOUDEM KANA, MD | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Principal Investigator: | Pierre Auguste DIEMUNSCH, MD | Hôpitaux Universitaires de Strasbourg |
More Information
No publications provided
| Responsible Party: | Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg |
| ClinicalTrials.gov Identifier: | NCT00409253 History of Changes |
| Other Study ID Numbers: | 3738 |
| Study First Received: | December 7, 2006 |
| Last Updated: | February 24, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Strasbourg, France:
|
PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE |
Additional relevant MeSH terms:
|
Eclampsia Hypertension Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Vascular Diseases Cardiovascular Diseases Nicardipine Urapidil Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Physiological Effects of Drugs Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013