THE TREATMENT OF HYPERTENSION ASSOCIATED WITH SEVERE PREECLAMPSIA.A RANDOMIZED CONTROLLED TRIAL OF URAPIDIL VERSUS NICARDIPINE.The URANIC trial.

Phase 1

• Conditions: Hypertension associated with severe pre eclampsia; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-002544-40-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-26
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 366

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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,<br>- to demonstrate better maternal tolerance of urapidil compared with nicardipine,<br>- to look at the drug interactions between antihypertensive agents and other drugs used in the treatment of PE (anaesthetic agents, furosemide, magnesium sulfate),<br>- to demonstrate the foetal and neonatal safety of urapidil after maternal administration,<br>- 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