hypertensive patients of either sex aged 40-69 years MedDRA version: 9.1 Level: HLGT Classification code 10057166 MedDRA version: 9.1 Level: SOC Classification code 10047065 MedDRA version: 9.1 Level: SOC Classification code 10047065 MedDRA version: 9.1 Level: SOC Classification code 10047065
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Enalapril
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical Form: Tablet
INN or Proposed INN: Ler
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled at Visit 1 into the run-in period if they meet all the following criteria: 1. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent; 2. Subjects aged 40-69 years (inclusive); 3. Medical history of arterial hypertension not controlled with ACE-inhibitors given as monotherapy. 4. Subjects satisfying any 3 of the following 5 criteria of metabolic syndrome, defined according to the criteria of the American Heart Association (Grundy et al, 2005): Elevated waist circumference (≥ 102 cm in men and ≥ 88 cm in women); Elevated triglycerides (≥ 150 mg/dl): Reduced HDL cholesterol (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled at Visit 1 into the run-in period if they meet any of the following criteria: 1. History of major cardiovascular events (i.e. myocardial infarction, angina, congestive heart failure) or cerebrovascular events (stroke, transient ischemic attacks); 2. Clinically significant cardiac arrhythmias (e.g. atrial fibrillation, atrial-ventricular block); 3. Blood creatinine levels > 1.2 mg/dl in women or > 1.3 mg/dl in men; 4. Albumin/Creatinine ratio in urines > 300 mg/g; 5. Concomitant diabetes mellitus (i.e. FPG > 126 mg/dl) or concomitant oral antidiabetic therapy; 6. Concomitant dyslipidemias treated with statines therapy; 7. Severe anaemia, defined as haemoglobin levels ≤ 10 g/dl; 8. History of other clinically significant cardiac, renal, neurologic, hepatic or endocrine diseases whose sequelae and/or treatments could interfere with the results of the present study; 9. Any other clinically significant abnormalities, as judged by the Investigator, in laboratory tests (haematology, blood chemistry) performed at the screening visit; 10. History of malignancy in the past 3 years; 11. History of alcohol or drug abuse; 12. Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; 13. Patients with metabolic or major psychiatric disorders that, in the view of the investigator, could compromise the patient?s participation in the study; 14. Patients unable to give a valid informed consent; 15. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 16. Patients who received any investigational new drug within the last 12 weeks; 17. Patients who have been previously enrolled in this study; 18. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective The primary objective of the study is to assess the effects of a 24-week treatment period with the two investigational medicinal products (IMPs) combinations on arterial stiffness (aortic pulse wave velocity, PWV).;Secondary Objective: Secondary objectives The secondary objectives of the study are to assess the effects of a 24-week treatment period with the two IMPs combinations on the following parameters: Parameters of pressure wave reflection (augmentation index - AIx) and central arterial pressure; Endothelial function: flow mediated dilation (FMD) of brachial artery; Sitting blood pressure and heart rate measured at clinics; 24-hour blood pressure monitoring (ABPM); Adverse events and adverse drug reactions: Metabolic effects (lipid and glucose profile, insulin-resistance); ECG parameters; Routine laboratory parameters (haematology, blood chemistry and urinalysis).;Primary end point(s): The primary efficacy variable of the study is the change from baseline to the end of treatment of the aortic PWV (m/sec) measured at the end of the 24 weeks of treatment. | — |
Countries
Italy
Outcome results
None listed