E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HYPERTENSIVE PATIENTS NON ADEQUATELY CONTROLLED ON THERAPY WITH ACE-I OR ARB + 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 | 10015488 |
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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 asses the efficacy in the decrease of office DBP of Canrenone (Luvion), an aldosterone antagonist in addition to a antihypertensive therapy with ACE-inhibitor/ARB + diuretic |
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E.2.2 | Secondary objectives of the trial |
To establish the best dosage in add on therapy of Canrenone, in term of efficacy and safety, between two dosages: 50 mg/die vs 100mg/die |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Male and female patients 2) Age between 45 and 75 3) BMI < 35 4) Patients treated with ACE-inhibitor/ARB + diuretic for at least 2 months at highest dosage and diuretic dosage 25mg/die 5) Patients with hypertension grade 1-2 according to Guideline 2007 ESH/ESC 6) Written informed consent form obtained by the patients |
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E.4 | Principal exclusion criteria |
1) Patients with blood pressure values > 180/110 mmHg 2) Treatment with any other diuretic than hydrochlorothiazide 3) Any acute pathology occurred within 3 months before enrolment that in Investigator opinion can interfere with the trial and patients health 4) Any active malignancy or any other non cardiac significant medical event that can be life threatening 5) HIV infected patients 6) Active hepatitis 7) Hepatic cirrhosis 8) History of drug and alcohol abuse 9) Pregnant women or women desiring conception during the study 10) Breast – feeding women 11) Patients who for whatever reason are not able to understand the study objectives or possible consequences 12) Treatment with any other antihypertensive drugs than ACE-inhibitor/ARB + diuretic 13) Treatment with cortisonic drugs 14) Patients with chronic heart failure 15) History of ovariectomy or mastectomy 16) Diabetes patients (glycemia > 126 mg/dL or therapy with hypoglycemic drug) 17) History of IMA or stoke within 1 year before enrolment 18) Patients with nephrotic syndrome 19) K+ > 5 mEcq/l 20) Patients with hyponatriemia (Na + < 5 mEcq/l) 21) Patients with creatinine 1,5 mg/L 22) Uricemia > 10 mg / dL (534.8 mol/L) 23) Glomerular filtration rate (GFR) calculated by MDRD formula (< 45 ml/min/1.73 mq) 24) Known hypersensitivity to Canrenone or any of the excipients 25) Patients unlikely to comply with the study 26) Previous participation in any trial within the last 3 months 27) Patients unwilling to give the written informed consent form |
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease in average office DBP (Visit 4 – visit 1) in subjects treated with canrenone |
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 10 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |