Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT00409253
Phase
PHASE3
Status
Unknown

Conditions

  • Hypertension During Pre-Eclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • URAPIDIL (EUPRESSYL*) — DRUG
    Urapidil (Eupressyl\*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
  • NICARDIPINE — DRUG
    Nicardipine : IV 6.25 mg bolus until PAD \>105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days

Study Details

The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients. * efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration. * safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

Key Dates

Start date
Jun 30, 2007
Status verified
Feb 2009
Primary completion
Jun 30, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Urapidil
  • Active Comparator: Nicardipine

Primary Outcome Measure

Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period. [ Time Frame: Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period ]

Central Contacts