HYPERTENSIVE PATIENTS NON ADEQUATELY CONTROLLED ON THERAPY WITH ACE-I OR ARB + DIURETIC MedDRA version: 9.1 Level: LLT Classification code 10015488
Conditions
Interventions
Trade Name: LUVION*40CPR 50MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Canrenone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
GIENNE PHARMA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female patients 2) Age between 45 and 75 3) BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 + 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;Primary end point(s): Decrease in average office DBP (Visit 4 – visit 1) in subjects treated with canrenone | — |
Countries
Italy
Outcome results
None listed