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

• Conditions: Essential hypertension; MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

• Registration Number: EUCTR2008-007681-30-IT
• Lead Sponsor: SOFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Outpatients aged 18-75 years
Male and female gender
Patients with essential hypertension currently taking one antihypertensive medication (ACE-inhibitor, AT1-antagonist, calcium-antagonist, diuretic or beta-blocker) in the last 3 months and not adequately controlled (office mean SBP ≥ 140 and/or DBP ≥ 90 mm Hg) 14
One or more additional cardiovascular risk factors among14:
- 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/l (46 mg/dL) in females, or on specific drug treatment
- Fasting plasma glucose 5.6?6.9 mmol/l (102?125 mg/dL) or on specific drug treatment for hyperglycemia
- Diabetes mellitus: fasting plasma glucose &#8805; 7.0 mmol/l (126 mg/dL) or postload plasma glucose >11.0 mmol/l (198 mg/dL) or on specific drug treatment
- Abdominal obesity: waist circumference >102 cm in males; >88 cm females or BMI &#8805;25 and <30 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
Orthostatic hypotension (difference between mean sitting and standing SBP &#8805;20 mmHg)
Body mass index &#8805;30 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 (>5.2 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 screening period)*
Severe concurrent pathology (cancer, AIDS, liver disease, etc.)
Females who are pregnant or lactating
Pre-menopausal woman who are of child-bearing potential and are not practicing acceptable methods of birth control, or DO NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.
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
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