Essential Hypetension MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: ZANIPRIL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ENALAPRIL MALEATO
CAS Number: 76095-16-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
RECORDATI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -both sexes, aged 65 - 85 years -hypertensive patients not well controlled by current CCB monotherapy -mean SSBP>=140 mmHg and/or SDBP>=90 mmHg at screening and after a 2 week run-in period -satisfactory compliance to study medication during the run-in period (80-120%) -available to return to all scheduled visits and to comply with protocol requirements -written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 (SSBP=180 mmHg or SDBP =110 mmHg) -Known or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, pheochromocytoma, etc) -Patients whose SSBP differs > 20 mmHg or SDBP differs > 10 mmHg on 3 immediately consecutive readings or patients with orthostatic hypotension (SBP decrease > 20 mmHg after standing) -History of allergy, hypersensitivity, intolerance or contraindication to dihydropyridine calcium antagonists or ACE inibitor -History of cerebrovascular complications (TIA, stroke, hypertensive encephalopathy) within 6 months before study start -History of cardiac complications (stable and unstable angina pectoris, myocardial infarction, by-pass, PTCA, congestive heart failure NYHA Class II-IV) within 6 months before study start -Left ventricular outflow obstruction, including aortic stenosis -Clinically significant ventricular or supraventricular arrhythmia -Concomitant diabetes mellitus (i.e. FPG > 126 mg/dl) or concomitant oral antidiabetic therapy -Severe renal dysfunction (creatinine clearance <30 ml/min) -Severe hepatic dysfunction -Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator’s assessment) -History of malignancy within the previous 5 years (skin cancer other than melanoma is an exception) -Use of prohibited concomitant medications, such as other antihypertensive agents outside what reported in the protocol, strong CYP3A4 inhibitors, cyclosporin, grapefruit juice -History of alcohol or drug abuse -Participation in another clinical trial within 30 days prior to entry into the present study -Any other condition, which, in the investigator`s judgement, renders the patient unable to complete the study or increases the risk to the patient or which prevents optimal participation in achieving the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to collect safety data in elderly patients requiring combination therapy with a ACE–I/CCB fixed dose combination (Lercanidipine/Enalapril) to improve their blood pressure control;Secondary Objective: not apllicable;Primary end point(s): SAFETY PARAMETERS -Orthostatic test -Heart rate -Serum creatinine -Plasma lipids, fasting blood glucose and insulin resistance (HOMA index) -Routine laboratory parameters -ECG parameters -Adverse events EFFICACY PARAMETERS -Change from baseline in sitting SBP at trough -Change from baseline in sitting DBP at trough -Responder rate (SSBP =20 mmHg) -Normalization rate (BP < 140/90 mmHg). | — |
Countries
Italy
Outcome results
None listed