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

NCT02558023 | Terminated Phase 3 DMC

• 1 other identifier: 5866
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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))

Conditions

Hypertension; Preeclampsia

Keywords

PRE-ECLAMPSIA; URAPIDIL; NICARDIPINE

Outcome Measures

Primary Outcomes (1)

• Blood pressure at two hours

  up to 4 days

Study Arms (2)

Urapidil

EXPERIMENTAL

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.

Drug: Urapidil

Nicardipine

ACTIVE COMPARATOR

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

Drug: Nicardipine

Interventions

Urapidil DRUG

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.

Urapidil

Nicardipine DRUG

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

Nicardipine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (2)

Service d'Anesthésie - CMCO

Schiltigheim, 67303, France

Location

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

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia

Interventions

urapidil; Nicardipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pierre DIEMUNSCH, PUPH

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 23, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 25, 2020

Record last verified: 2019-08

Locations

FR (2)