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

Primary Purpose

Hypertension, Preeclampsia

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Urapidil
Nicardipine
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring PRE-ECLAMPSIA, URAPIDIL, NICARDIPINE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Anesthésie - CMCO
  • Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Urapidil

Nicardipine

Arm Description

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 : 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

Outcomes

Primary Outcome Measures

Blood pressure at two hours

Secondary Outcome Measures

Full Information

First Posted
August 24, 2015
Last Updated
August 20, 2020
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02558023
Brief Title
The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
Acronym
Uranic
Official Title
The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
no candidats
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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))

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Preeclampsia
Keywords
PRE-ECLAMPSIA, URAPIDIL, NICARDIPINE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urapidil
Arm Type
Experimental
Arm Description
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.
Arm Title
Nicardipine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Urapidil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicardipine
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood pressure at two hours
Time Frame
up to 4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre DIEMUNSCH, PUPH
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Anesthésie - CMCO
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
Facility Name
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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