Hypertension During Pre-EclampsiaPhase 3NCT00409253
Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
A Phase 3 study testing URAPIDIL (EUPRESSYL*) and NICARDIPINE in people with Hypertension During Pre-Eclampsia, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Hypertension During Pre-Eclampsia
- What is being tested?
- URAPIDIL (EUPRESSYL*) and NICARDIPINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2007to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Hôpital Saint-Jacques, CHU de Besançon
Besançon, 25000
Myriam KRAUSZ-GRIGNARD, MD, 33381219014, mgrignardkrausz@chu-besancon.fr
Myriam KRAUSZ-GRIGARD, MD
- Recruiting
Maternité A. PINARD
Nancy, 54042
HERVE BOUAZIZ, MD, 33383344490, h.bouaziz@chu-nancy.fr
Hervé BOUAZIZ, MD
- Recruiting
Sihcus-Cmco
Schiltigheim, 67303
Rita VIZITIU, MD, 33388628404, rita.vizitiu@chru-strasbourg.fr
Rita VIZITIU, MD
- Recruiting
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Pierre Auguste DIEMUNSCH, MD, 33.3.88.12.70.78, Pierre.Diemunsch@chru-strasbourg.fr
Pierre Auguste DIEMUNSCH, MD
About this study
Official title: 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).
- Conditions
- Hypertension During Pre-Eclampsia
- Being tested
- URAPIDIL (EUPRESSYL*), NICARDIPINE
- Keywords
- PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
NICARDIPINEDrug
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 group | Role | What they receive |
|---|---|---|
| Urapidil | Active comparator | Not described Receives: Drug: URAPIDIL (EUPRESSYL*) |
| Nicardipine | Active comparator | Not described Receives: Drug: NICARDIPINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (1)
-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
Measured: During the first 48hour of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startJun 2007
- Primary completionJun 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension During Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Auguste DIEMUNSCH, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409253
- Sponsor's protocol ID
- 3738
- Status last verified
- Feb 2009
- First submitted
- 7 Dec 2006
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.
PubMed 26148170
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE
- ClinicalTrials.gov ID
- NCT00409253
- Acronym / sponsor ID
- 3738
- Conditions
- Hypertension During Pre-Eclampsia
- Keywords
- PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urapidil | Active comparator | Drug: URAPIDIL (EUPRESSYL*) |
| Nicardipine | Active comparator | Drug: NICARDIPINE |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URAPIDIL (EUPRESSYL*)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. | Drug | Urapidil |
| NICARDIPINENicardipine : 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 | Drug | Nicardipine |
Primary outcome
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
1 secondary outcome
-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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
- Derived from this study: PubMed 26148170Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Auguste DIEMUNSCH, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing URAPIDIL (EUPRESSYL*) and NICARDIPINE in people with Hypertension During Pre-Eclampsia, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Auguste DIEMUNSCH, MD (33.3.88.12.70.78, Pierre.Diemunsch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009.