Study on the vascular effects of ACE-I + CA-antagonist (Enalapril + Lercanidipine) versus ACE-I + diuretic (Enalapril + hydrochlorothiazidE) combinations in hypertensive patients with metabolic syndrome not sufficiently controlled by ACE-I monotherapy - ND

• Conditions: hypertensive patients of either sex aged 40-69 years; MedDRA version: 9.1Level: HLGTClassification code 10057166; MedDRA version: 9.1Level: SOCClassification code 10047065

• Registration Number: EUCTR2008-005006-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 (&#8805; 102 cm in men and &#8805; 88 cm in women); Elevated triglycerides (&#8805; 150 mg/dl): Reduced HDL cholesterol (< 40 mg/dl in men and < 50 mg/dl in women); Elevated blood pressure (SBP &#8805; 130 mmHg or DBP &#8805; 85 mmHg); Elevated fasting plasma glucose (FPG &#8805; 100 mg/dl) or drug treatment for elevated glucose levels; 5. Patient?s co-operative attitude and able to adhere to study protocol procedures and timelines. At visit 2 (end of run-in), after 4 weeks of treatment with Enalapril 20 mg once daily, patients will be randomised in the treatment phase if they meet the following criteria: 6. SBP 140-159 mmHg and DBP 90-99 mmHg.
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

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 &#8804; 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified