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
ConditionsHypertension associated with severe pre eclampsiaTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsEupressyl
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.
Investigators
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
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