EFFICACY AND SAFETY OF ZOFENOPRIL + HYDROCHLOROTHIAZIDE COMBINATION VS. IRBESARTAN + HYDROCHLOROTHIAZIDE COMBINATION IN ESSENTIAL HYPERTENSIVE PATIENTS NOT CONTROLLED BY PREVIOUS MONOTHERAPY + AMENDMENT 1 (VERSION FINAL, DATED 07.11.2008)

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 mean 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 ? 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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