Clinical trial NCT02558023: The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
Official title: The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Preeclampsia
Keywords: PRE-ECLAMPSIA
URAPIDIL
NICARDIPINE
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.

* efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
* safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).

Pharmacokinetic study included to study :

* transplacental transfer,
* transfer in breast milk,
* and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))


Eligibility 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 Pregnancy Induced Hypertension (PIH), as defined by :

Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,

* Written informed consent signed and dated by both investigator and patient,
* Valid social security affiliation

Exclusion Criteria:

* Known allergy to 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 responsibility,
* 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

Primary outcomes:
measure: Blood pressure at two hours
timeFrame: up to 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Service d'Anesthésie - CMCO
city: Strasbourg
country: France
facility: Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Pierre DIEMUNSCH, PUPH
role: PRINCIPAL_INVESTIGATOR
References: