Essential hypertension MedDRA version: 12.0 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Zanidip
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LERCANIDIPINE HYDROCHLORIDE
CAS Number: 100427-26-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Recordati S.p.A.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, aged 18 - 75 years. - If females, the patient must be post-menopausal, surgically sterilized or, if child-bearing potential, non nursing and practicing an effective method of contraception throughout study duration (i.e. using oral or implanted contraceptive therapy or an intrauterine device). If naturally post-menopausal, the patient must not have had a menstrual period within 12 months prior to entry into the study. - Non-hospitalized patients. - Patients with essential hypertension (untreated or intolerant or not well controlled on current antihypertensive therapy), who are able to tolerate a drug-free period. - Office BP: sitting diastolic blood pressure (SDBP) between 100 and 109 mmHg (inclusive) and clinic sitting systolic blood pressure (SSBP) = 85 mmHg in the last week of the run-in period. - Normal ECG or with signs of LVH, first degree AV block, non specific ST-T wave changes, or other changes not considered clinically significant. - Satisfactory compliance to study medication (80-120%) during the run-in period. - 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) 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 (SSBP >= 180 mmHg or SDBP >= 110 mmHg) - Patients with persistent differences in blood pressure between the two arms (>20 mmHg for SSBP or >10 mmHg for SDBP) on 3 immediately consecutive readings at Visit 1 - Known or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, pheochromocytoma, etc.) - History of cerebrovascular complications (TIA, stroke, hypertensive encephalopathy) History of cardiac complications (stable and unstable angina pectoris, myocardial infarction, by-pass, PTCA, congestive heart failure NYHA Class II-IV) - Hemodynamically significant valve disease, including aortic stenosis - Clinically significant ventricular or supraventricular arrhythmia; heart rate >100 beats/min - Type 1 or Type 2 diabetes on drug treatment - Severe renal or hepatic insufficiency - Clinically important abnormal laboratory findings during the run-in period: . Serum Creatinine >2 mg/dL . AST (SGOT) and/or ALT (SGPT) and/or GGT > 3 times the upper limit of normal . Fasting Plasma Glucose >= 126 mg/dL . Hemoglobin 5.5 mmol/L . Serum Sodium < 132 mmol/L - Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigators assessment) - History of malignancy within the previous 5 years (skin cancer other than melanoma is an exception) - History of alcohol or drug abuse within the previous 2 years - History of allergy, hypersensitivity, intolerance or contraindication to dihydropyridine calcium antagonists or ACE inibitor - Use of prohibited concomitant medications, including vasoactive products, strong inhibitors of CYP3A4, ciclosporin and grapefruit juice (see Section 6.7 of study protocol) - 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 this study is to evaluate the optimal dose combinations of lercanidipine and enalapril as initial treatment of patients with moderate essential hypertension.;Secondary Objective: The secondary objectives are to evaluate the combinations of lercanidipine and enalapril compared to the single components and with placebo in terms of efficacy, safety and tolerability in this patient population.;Primary end point(s): The primary efficacy parameter is the change from baseline in mean office SDBP at trough (24 ± 2 hours post-dose) after 10 weeks of double-blind treatment. | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed