Hypertension associated with severe pre eclampsia
Conditions
Interventions
Trade Name: Eupressyl
Pharmaceutical Form: Solution for injection
Product Name: nicardipine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: nicardipine
CAS Number: 54527-84-3
Other
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adult patients •Singleton pregnancy •Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated •Patient with PE, as defined by : Systolic Blood Pressure (BP) = 140 mmHg and/or Diastolic BP = 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick, OR •Patient with severe PIH, as defined by : Systolic BP = 160mmHg and/or Diastolic BP =110mmHg, after the 20th week of amenorrhea, without chronic hypertension, •Written informed consent signed and dated by both investigator and patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 366 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Known allergy to the study drugs • Contra-indication to the study drugs :stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days. •Eclampsia •Person with difficulty understanding information •Person with diminished responsiblity, •Ongoing intravenous antihypertensive treatment, •No pressure cuff adapted to the morphology of the arms of the patients •Concomitant use of 5 phosphodiesterase inhibitors •Participation in a clinical trial within 6 months prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if urapidil is non-inferior to nicardipine by a maximum margin of 10% on the success rate. ;Secondary Objective: - to compare the ease of use of urapidil with the ease of use of nicardipine, - to demonstrate better maternal tolerance of urapidil compared with nicardipine, - to look at the drug interactions between antihypertensive agents and other drugs used in the treatment of PE (anaesthetic agents, furosemide, magnesium sulfate), - to demonstrate the foetal and neonatal safety of urapidil after maternal administration, - to study the pharmacokinetics (PK) of urapidil after intravenous administration in course of the management of hypertension in PE (Transplacental transfer,Transfer to breast milk, Neonatal drug elimination in the moderately preterm baby (<33 WG).);Primary end point(s): Lowering the mean arterial blood pressure (MAP) between 100 and 120 mmHg.;Timepoint(s) of evaluation of this end point: 2 hours following start treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy criteria: time needed to reach the therapeutic success, drug dose required to achieve therapeutic success, number of drug infusion rate adaptations, need for another antihypertensive agent, recurrence of hypertension after discontinuation of iv treatment, need for a therapeutic relay, evolution of systolic and diastolic blood pressure during antihypertensive therapy, Tolerance criteria: occurrence of maternal hypotension, occurrence of maternal tachycardia, occurrence of the maternal, foetal or neonatal side effects described for urapidil and nicardipine, need for treatment interruption due to side effects, Evolution of the pregnancy: coexistent treatment, complication of PE, obstetrical data, Drug interaction: signs of magnesium overdose, drug interaction with anaesthetic agents, furosemide, Anaesthetic data: type of labour analgesia and / or anaesthesia for Caesarean Section (spinal, epidural, systemic intravenous opioids, no anaesthesia) Neonatal data: Umbilical cord pH, Agar score, tachycardia, hypotension, need for intubation, duration of mechanical ventilation, side effects, Pharmacokinetic substudy: •Trans-placental transfer: At birth: determination of urapidil concentration in maternal blood and in the arterial and venous umbilical cord blood •Transfer in breast milk: After childbirth, daily determination of the urapidil and nicardipine concentration in systematic blood and breast milk samples during and up to 24 hours after stopping the administration of the antihypertensive drug, •Neonatal Elimination: Determinations of the urapidil concentration in the blood of moderately prematurate babies of mothers treated with urapidil (less than 33 WG) at ICU admission (H 2) and at 24 hours in systematic blood samples. ;Timepoint(s) of evaluation of this end point: Efficacy criteria : end of the treatment Tolerance criteria : until the end of the treatment Evolution of the pregnancy : until delivery Data anest | — |
Countries
France
Contacts
Public ContactDRCI
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed