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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-000727-17-NL |
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Date of registration:
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01/03/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Maternal, uteroplacental and fetal haemodynamic effect of Nicardipine in severe pre-eclampsia. - CORCA II
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Scientific title:
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Maternal, uteroplacental and fetal haemodynamic effect of Nicardipine in severe pre-eclampsia. - CORCA II |
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Date of first enrolment:
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23/08/2007 |
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Target sample size:
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10 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000727-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
severe pre-eclampsia
sigleton pregnancy between 23 and 35 weeks
admission in High Care obstetric ward
intra-arterial blood pressure registration
systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 110 mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
structural cardiac anomaly
contra-indication for study medication
indication for Intensive Care admission (ventilation support, dialysis, ...)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Hypertensive crisis in patients with severe pre-eclampsia needs to be treated to prevent maternal and fetal complications.
The maternal, uteroplacental and fetal haemodynamic respose to antihypertensive treatment with Nicardipinehydrochloride will be evaluated in detail by materal echocardiography and fetal doppler ultrasound as well as by the effect on plasma Brain Natriuretic Peptide concentration (BNP) and parameters of the Renin- Angiotensin- Aldosterone system (RAAS).
MedDRA version: 9.1
Level: LLT
Classification code 10040445
Term: Severe pre-eclampsia, antepartum
MedDRA version: 9.1
Level: LLT
Classification code 10053094
Term: Doppler echocardiography
MedDRA version: 9.1
Level: LLT
Classification code 10045412
Term: Ultrasound Doppler
MedDRA version: 9.1
Level: LLT
Classification code 10058179
Term: Hypertensive emergency
MedDRA version: 9.1
Level: LLT
Classification code 10038555
Term: Renin
MedDRA version: 9.1
Level: LLT
Classification code 10002491
Term: Angiotensin II
MedDRA version: 9.1
Level: LLT
Classification code 10053406
Term: Brain natriuretic peptide
MedDRA version: 9.1
Level: LLT
Classification code 10001644
Term: Aldosterone
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Intervention(s)
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Trade Name: Cardene
Product Name: Nicardipinehydrochloride
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NICARDIPINE HYDROCHLORIDE
CAS Number: 54527843
Concentration unit: mg/h milligram(s)/hour
Concentration type: up to
Concentration number: 0.5-10
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Primary Outcome(s)
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Primary end point(s): blood pressure
maternal cardiac function (systolic, diastolic)
uteroplacental and fetal doppler
BNP
RAAS
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Secondary Objective: The effects of Nicardipine treatment of a hypertensive crisis in severe pre-eclampsia on the plasma Brain Natriuretic Peptide concentration and parameters of the Renin-Angiotensin-Aldosterone system as well as the correlation of these parameters with the maternal haemodynamics
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Main Objective: To investigate in detail the haemodynamic effects of antihypertensive treatment with Nicardipine of a hypertensive crisis in patients with severe pre-eclampsia. The effects will be investigated by maternal cardiac ultrasound and doppler ultrasound of the uteroplacental and fetal circulation.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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