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

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 3

Conditions: Hypertension; Preeclampsia

Treatments: Drug: Urapidil; Drug: Nicardipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02558023

5866

Details and patient eligibility

About

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))

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Urapidil

Experimental group

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.

Treatment:

Drug: Urapidil

Nicardipine

Active Comparator group

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

Treatment:

Drug: Nicardipine