E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040445 |
E.1.2 | Term | Severe pre-eclampsia, antepartum |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053094 |
E.1.2 | Term | Doppler echocardiography |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045412 |
E.1.2 | Term | Ultrasound Doppler |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058179 |
E.1.2 | Term | Hypertensive emergency |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038555 |
E.1.2 | Term | Renin |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002491 |
E.1.2 | Term | Angiotensin II |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053406 |
E.1.2 | Term | Brain natriuretic peptide |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001644 |
E.1.2 | Term | Aldosterone |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal exclusion criteria |
structural cardiac anomaly contra-indication for study medication indication for Intensive Care admission (ventilation support, dialysis, ...) |
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E.5 End points |
E.5.1 | Primary end point(s) |
blood pressure maternal cardiac function (systolic, diastolic) uteroplacental and fetal doppler BNP RAAS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |