The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

Hypertension Clinical Trial

— Uranic  

Official title:

The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02558023
• Other study ID #: 5866
• Status: Terminated
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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))

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Urapidil
Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg. The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes. Maximum dose of 30 mg.h-1.
• Nicardipine
Nicardipine : IV 1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes. Maximum dose of 6 mg.h-1

Locations

Country	Name	City	State
France	Service d'Anesthésie - CMCO	Schiltigheim
France	Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure at two hours		up to 4 days