Patients with essential hypertension and with at least one additional cardiovascular risk factor, not controlled by a previous monotherapy MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Zofenopril and diuretics
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 102 cm in males; >88 cm females or BMI ≥25 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the combination zofenorpil + hydrochlorothiazide is at least as effective as the irbesartan + hydrochlorothiazide combination in reducing office sitting diastolic blood pressure after 18 weeks of double-blind treatment in essential hypertensive patients not controlled by a previous monotherapy with ACE-inhibitor or AT1-antagonist or diuretic or calcium antagonist or beta-blocker and with one or more additional cardiovascular risk factors (smoking, hypercholesterolemia, diabetes mellitus, abdominal obesity, family history of premature cardiovascular disease);Secondary Objective: Secondary objectives will be the assessment of the efficacy of the two drug combinations after 18 weeks of double-blind treatment on office systolic blood pressure, on ambulatory blood pressure, on hs-CRP and on office sitting blood pressure after 32 weeks of treatment in patients who perform the extension phase;Primary end point(s): Office sitting diastolic blood pressure change after 18 weeks of treatment (Visit 3b ? baseline) | — |
Countries
Greece, Italy, Lithuania
Outcome results
None listed