Primary Hypertension and Obesity MedDRA version: 21.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Inosamin® 25mg
Pharmaceutical Form: Tablet
INN or Proposed INN: EPLERENONE
Other descriptive name: EPLERENONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Institute for study, research, education and therapy of vascular, heart, brain and kidney nosologies (I.N.A.K.E.N)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 30-75 years of age 2. Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg 3. Confirmation of arterial hypertension by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg 4. Obesity, confirmed estimated by Body Mass Index (BMI) of 30-39.99 kg/m2 5. ?nformed written consent 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical trial with an Investigational Product or an invasive device during the study or the last 6 months 2. Secondary arterial hypertension 3. Recent ( 5.5) 9. Hemodynamically significant valvular heart diseas 10. Addison’s disease 11. Pregnancy, planning to conceive or women of childbearing potential, not using effective contraception 12. Scheduled surgery or cardiovascular surgery over the next 6 months 13. Absolute contra-indication to any of the study drugs 14. Requirement for study drug for reason other than to treat hypertension, (eg, ß-blockers for angina or aldosterone antagonists for heart failure) 15. Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy) 16. Patient with a contemporary systemic disease with a life expectancy less than the end of the study 17. Any situation which, in the judgment of the investigator, may adversely affect the efficacy and / or safety of the Investigational Product (alcohol abuse, drug use, mental retardation) 18. Patient treated with systemic corticosteroids at least 3 months prior to the the study screening 19. Patient receiving a-inhibitors with the exception of aflucosin and tamsulosin for prostatic symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the eplerenone based antihypertensive therapeutic strategy against the irbesartan-based antihypertensive therapeutic strategy for the reduction of the 24-hour ambulatory blood pressure in obese hypertensive patients over a 24-week follow-up.;Secondary Objective: 1. Comparison of the eplerenone based antihypertensive treatment strategy against the irbesartan-based antihypertensive therapeutic strategy to reduce 24-hour ambulatory blood pressure over 8 and 16 weeks of follow-up. 2. Comparison of the eplerenone-based antihypertensive therapeutic strategy against the irbesartan-based antihypertensive therapeutic strategy for reducing blood pressure in a 8, 16, and 24-week follow-up. 3. Comparison of the eplerenone-based antihypertensive treatment strategy against the irbesartan-based antihypertensive therapeutic strategy with respect to the blood pressure control rate over 8, 16 and 24 weeks of follow-up. ;Primary end point(s): Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 24 weeks.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8 and 16 weeks. 2. Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8 and 16 weeks. 3. Frequency of controlled hypertension in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8, 16 and 24 weeks. ;Timepoint(s) of evaluation of this end point: 1. Week 6 and week 16 2. Week 6 and week 16 3 . Week 6 , 16 and 24 | — |
Countries
Greece
Outcome results
None listed