primary hypertension MedDRA version: 9.1 Level: HLGT Classification code 10057166
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Lercanidipine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical Form: Tablet
INN or Proposed INN:
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertension is defined as a mean lying systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg at the screening visit, both in never patients and in those previously treated (non responders). Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. • The mean systolic and diastolic blood pressures are defined as the arithmetic mean of 3 consecutive readings taken at 1 minute intervals after 5 minutes of repose. • Age range: 30-70 years. Only postmenopausal women will be included. • Signed Informed Consent obtained by 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
Exclusion criteria: • Severe hypertension (systolic blood pressure = 180 mm Hg, diastolic blood pressure =110 mm Hg). • Secondary hypertension (Renovascular hypertension, aortic coarctation, primary aldosteronism, phaeochromocytoma, etc.) • Hypersensibility, allergy or contraindication to the use of ACE inhibitors, calcium channel blockers, diuretics. • Cerebrovascular accident or transient ischemic attacks in the last 6 months. • Angina pectoris, Myocardial infarction; percutaneous coronary angioplasty or coronary artery bypass surgery, heart failure NYHA II-IV within last 6 months. • Clinically significant AV conduction disturbances and/or arrhythmias (e.g. second- or third-degree AV block; Sick-sinus syndrome or clinically significant bradycardia- resting heart rate 126 mg/dl, or current treatment for diabetes) • Severe renal failure (creatinine clearance <30 ml/min). • Severe liver failure • Any other concurrent severe disease which could preclude participation or survival (according to the physician’s judgment). • Malignant neoplasms in the last 5 years (apart from skin cancer different from melanoma) • Use of other antihypertensive drugs apart from what reported in the protocol, cyclosporine, grapefruit juice, dugs inhibiting CYP3A4. • Patients who are currently abusing or previously abused alcohol or other drug substances (within past two years). • Patients participating in other clinical trials in the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the present study is to evaluate the effects of two combination treatments (lercanidipine + enalapril, lercanidipine + hydrochlorothiazide) on blood pressure and EPC.;Secondary Objective: na;Primary end point(s): EPC number in hypertensive patients | — |
Countries
Italy
Outcome results
None listed