| December 7, 2006 |
| February 24, 2009 |
| June 2007 |
| June 2010 (final data collection date for 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 ] [ Designated as safety issue: Yes ] |
| 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. |
| Complete list of historical versions of study NCT00409253 on ClinicalTrials.gov Archive Site |
| -maternal and foetal ultrasonography, biology and clinical assessment-type of delivery-post-partum bleeding-neo-natal evaluation by neonatologist during the first 48 hours of life [ Time Frame: During the first 48hour of life ] [ Designated as safety issue: Yes ] |
| -maternal and foetal ultrasonography, biology and clinical assessment-type of delivery-post-partum bleeding-neo-natal evaluation by neonatologist during the first 24 hour of life |
| |
| Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine |
| Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE |
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).
|
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Hypertension During Pre-Eclampsia |
- Drug: URAPIDIL (EUPRESSYL*)
- Drug: NICARDIPINE
|
| |
| |
| |
| Recruiting |
| 72 |
| August 2010 |
| June 2010 (final data collection date for primary outcome measure) |
Inclusion criteria:
- patients 'written informed consent dated and signed by investigator and patient
- affiliation to a social security system
- single pregnancy
- arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe pre-eclampsia
Exclusion criteria:
- patient under 18 year old or unable to give informed consent
- protocol rejected by patient-impossibility to use non invasive blood pressure monitoring
- antihypertensive treatments within 24h before inclusion
- allergy to or contraindication for one of the study drugs-pre
- eclampsia that does not require an antihypertensive treatment
- acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs
- participation to a therapeutic protocol within 6 months prior to the start of study
|
| Female |
| 18 Years to 51 Years |
| No |
|
|
| France |
| |
| NCT00409253 |
| Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg |
| 3738 |
| University Hospital, Strasbourg, France |
|
| Principal Investigator: |
Pierre Auguste DIEMUNSCH, MD |
Hôpitaux Universitaires de Strasbourg |
|
|
| University Hospital, Strasbourg, France |
| February 2009 |
