EFFICACY AND SAFETY OF ZOFENOPRIL + HYDROCHLOROTHIAZIDE COMBINATION VS IRBESARTAN + HYDROCHLOROTHIAZIDE COMBINATION IN ESSENTIAL HYPERTENSIVE PATIENTS NOT CONTROLLED BY PREVIOUS MONOTHERAPY - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

Outpatients aged 18-75 years Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner) Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test Patients with essential hypertension currently taking one antihypertensive medication (ACE-inhibitor, AT1-antagonist, diuretic, calcium antagonist, beta-blocker) and not adequately controlled (office DBP ≥ 90 mm Hg) One or more additional cardiovascular risk factors among: - Smoking - Total cholesterol >5.0 mmol/l (190 mg/dL) or on specific drug treatment - LDL cholesterol >3.0 mmol/l (115 mg/dL) or on specific drug treatment - HDL cholesterol <1.0 mmol/l (40 mg/dL) in males; <1.2 mmol/ (46 mg/dL) in females, or on specific drug treatment - Diabetes mellitus controlled by diet or antidiabetic treatment (HbA1c < or equal 7.5%) - Abdominal obesity: waist circumference >102 cm in males; >88 cm females or BMI ≥25 and < or equal 32 kg/m2 - Family history of premature cardiovascular disease (males at age <55 years; females at age <65 years) Able and willing to sign informed consent and to comply with study procedures Written informed consent of the patient
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

Malignant or secondary hypertension Systolic isolated hypertension Orthostatic hypotension (difference between mean sitting and standing SBP ≥20 mmHg) Body mass index >32 kg/m2 Arm circumference <24 and >32 cm Heart failure requiring medical treatment Myocardial infarction in the 6 months prior to enrolment Cerebrovascular events in the previous 6 months Cardiogenic or septic shock 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 normal upper limit)* Bilateral renal arterial stenosis, or unilateral for patients with a single kidney Renal insufficiency (creatininemia >200 µmol/L or 2 mg/dL) Hypokalemia (<3.5 mEq/L) or hyperkalemia (>5.0 mEq/L) in at least two haematological examinations (if the patient presents at baseline hypo or hyperkalemia, this value has to be confirmed by a new examination to be performed during run-in period) Severe concurrent pathology (cancer, AIDS, liver disease, etc.) Females who are pregnant or lactating 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 products 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 (investigator?s decision) by the start of the run-in period. Participation in other clinical trials in the previous one month Conditions which in the investigator?s opinion may interfere with the study?s execution or due to which the patient should not participate for safety reasons Risk of low patient cooperation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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