Skip to main content
Clinical Trials/EUCTR2014-002544-40-FR
EUCTR2014-002544-40-FR
Active, not recruiting
Phase 1

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

Hôpitaux Universitaires de Strasbourg0 sites366 target enrollmentJune 26, 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypertension associated with severe pre eclampsia
Sponsor
Hôpitaux Universitaires de Strasbourg
Enrollment
366
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Hôpitaux Universitaires de Strasbourg

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,
  • Proteinuria \> 300 mg.day\-1 or \> 2 crosses(\+\+) on an urinary dipstick,
  • 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

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.
  • 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

Outcomes

Primary Outcomes

Not specified

Similar Trials