PATIENTS affected by METABOLIC SYNDROME WITH ESSENTIAL HYPERTENSION NOT CONTROLLED BY PREVIOUS MONOTHERAPY MedDRA version: 9.1 Level: LLT Classification code 10052066
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Zofenopril and diuretics
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
A. MENARINI I.F.R.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients aged ≥ 18 years Caucasian males and females Diagnosis of essential hypertension according to Guidelines of European Society of Cardiology. Fasting plasma glucose ≥ 100mg/dL or on drug treatment for elevated glucose One or more of the following criteria: 1) Waist circumference ≥102 cm in men and ≥88 cm in women 2) Serum triglycerides ≥ 150 mg/dL or on drug treatment for elevated triglycerides* 3) HDL cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Serum level of HDL cholesterol 1000 and/or LDL-C > 190 mg/dL Malignant or secondary hypertension Systolic isolated hypertension Orthostatic hypotension (difference between mean sitting and standing SBP ≥ 20 mmHg) Heart failure requiring medical treatment Myocardial infarction in the 6 months prior to enrolment cerebrovascular events (including stroke or transient ischemic attack) in the previous 6 months Haemodynamically significant valvulopathy Hereditary/idiopathic angioedema History of angioedema associated with previous ACE-inhibitor therapy Liver pathology (AST or ALT > 3 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than upper limit) Bilateral renal arterial stenosis, or unilateral for patients with a single kidney Renal insufficiency (creatininemia > 200 ?mol/L or 2 mg/dL) Hypokalemia ( 5.0 mEq/L) at least two haematological examinations (if the patient presents at baseline hypo or hyperkalemia, this value has to be confirmed either by a previous examination or by a new one within 3 days) Hyponatremia ( 145 mEq/L) Hypercalcemia: (serum Ca) + [(4 serum albumin) x 0,8] > 10,2 mg/dl Hyperuricemia (uric acid > 7 mg/dL) Patients receiving dialysis Hereditary galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorpion Severe concurrent other diseases (cancer, AIDS, liver disease, etc.) Positive history for renal transplantation Dementia, psychosis, alcoholism (> 350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the patient Hypersensitivity or contraindications to use of the product under study History of undesired side effects with ACE-inhibitors, AT1-antagonists or diuretics Current treatment with any antihypertensive agents that cannot be safely stopped (investigators decision) by the start of the run-in period Participation in other clinical trials in the previous 4 months Conditions which in the investigators opinion may interfere with the studys execution or due to which the patient should not participate for safety reasons Risk of low patient cooperation Females who are pregnant or lactating Females of childbearing potential not using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Office diastolic blood pressure change at study end (24 weeks baseline);Main Objective: The primary study objective is to determine whether the combination zofenopril + hydrochlorothiazide is at least as effective as the irbesartan + hydrochlorothiazide combination in reducing office diastolic blood pressure in metabolic syndrome patients with essential hypertension not controlled by a previous monotherapy.;Secondary Objective: Secondary objectives are the assessment of efficacy on office blood pressure and and on metabolic parameters (fasting blood glucose, HBA1C, triglycerides, HDL cholesterol, plasma insulin, insulin resistance -HOMA-IR-), waist circumference, and renal function (creatinine clearance assessed by Cockroft-Gault formula and albumin-creatinine ratio, microalbuminuria). In a subgroup of about 20% of study population/total randomised patients, in selected centres, the efficacy of the two drug on ambulatory blood pressure will be evaluated (24 hour, day-time, night-time, morning and last 6 hour ambulatory blood pressure averages, raise in morning blood pressure, smoothness index, Ambulatory Arterial Stiffness Index or AASI). | — |
Countries
Italy
Outcome results
None listed