Essential hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: BIFRIZIDE
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IDROCLOROTIAZIDE
CAS Number: 58-93-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
LUSOFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 ≥25 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Malignant or secondary hypertension Orthostatic hypotension (difference between mean sitting and standing SBP ≥20 mmHg) Body mass index ≥30 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 (5.2 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 normalizing or reducing blood pressure in patients with essential hypertension not controlled by a previous monotherapy and with one ore more additional cardiovascular risk factors;Secondary Objective: Secondary objectives are the assessment of efficacy on office systolic blood pressure and on ambulatory blood pressure, and on a marker of target organ damage such as left ventricular hypertrophy (LVH) quantified by calculation of the left ventricular mass index (LVMI) detected by echocardiography and electrocardiography (ECG), carotid intima-media thickness (IMT), renal function (creatinine clearance assessed by Cockroft-Gault formula) and subclinical renal damage (urinary albumin-creatinine ratio).;Primary end point(s): Percentage of subjects with office sitting blood pressure <140/90 mmHg (<130/80 mmHg in diabetics or patients with at least 3 risk factors) or with an office systolic blood pressure reduction of at least 20 mmHg or a sitting diastolic blood pressure reduction of at least 10 mmHg after 18 weeks of treatment (responders) (visit 3b ? baseline) | — |
Countries
Italy
Outcome results
None listed