E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
arterial hypertension resistant to treatment (target blood pressure not reached with a combination of at least three different antihypertensive drugs, one of them being a diuretic) |
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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 | 10020783 |
E.1.2 | Term | Hypertension not adequately controlled |
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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 | 10020775 |
E.1.2 | Term | Hypertension arterial |
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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 | 10038274 |
E.1.2 | Term | Refractory hypertension |
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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 |
The primary aim is to show a statistically significant difference between the fall of average daily systolic and diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) at the start of the study and after 8 weeks in groups treated by spironolactone and placebo. |
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E.2.2 | Secondary objectives of the trial |
Secondary aims are to compare the changes of serum potassium, natrium, creatinine, microalbuminuria, body weight, and casual blood pressure in office between groups and to assess the treatment response in different baseline levels of aldosterone and aldosterone/PRA ratio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Only patients with resistant hypertension aged over 18 years will be enrolled. Resistant hypertension is defined as blood pressure during clinical control exceeding 140/90 mmHg (average of 2nd and 3rd measurement during one visit, with at least 3-5 minutes between separate measurements) despite adherence to treatment with full doses of at least three antihypertensive medications, including a diuretic. In diabetic patients or in patients with renal disease (i.e., with a creatinine level of more than 133 μmol per liter or urinary protein excretion of more than 300 mg over a 24-hour period) a blood pressure over 130/80 mmHg despite adherence to treatment with full doses of at least three antihypertensive medications including a diuretic is considered to be resistant. Patients will sign informed consent before enrollment to the study.
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E.4 | Principal exclusion criteria |
Following patients will not be enrolled: patients with grade 3 hypertension (systolic BP over 180 mmHg and/or diastolic over 110 mmHg) who need immediate treatment; patients with renal failure (acute or chronic) with creatinine exceeding 180 umol/l or glomerular filtration below 40 ml/min (based on MDRD calculation), hyperkalemia over 5,4 mmol/l, hyponatremia below 130 mmol/l, porphyria, hypersensitivity to components of the drug Verospiron (Richter Gedeon, Hungary), women in gravidity or lactation period or women in productive age not using any of contraceptive methods, and patients who already use any of the aldosterone antagonists (spironolactone, epleronone, kanreone). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference between the fall of average daily systolic and diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) at the start of the study and after 8 weeks in groups treated by spironolactone and placebo. |
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | Yes |
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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in case that preliminary analyses show statistically significant difference before all subjects are enrolled |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |