AN INTERNATIONAL MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND TRIAL TO EVALUATE DIFFERENT DOSE COMBINATIONS OF LERCANIDIPINE AND ENALAPRIL IN COMPARISON WITH EACH COMPONENT ADMINISTERED ALONE AND WITH PLACEBO IN PATIENTS WITH ESSENTIAL HYPERTENSION - REC 15/2375 IT CL 0336
- Conditions
- Essential hypertensionMedDRA version: 12.1Level: LLTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2009-015988-13-IT
- Lead Sponsor
- RECORDATI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 990
- 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) < 180 mmHg after a 2 week placebo run-in period. - Home BP: diastolic blood pressure at home >= 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
- 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 <10 g/dL. . Serum Potassium >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the optimal dose combinations of lercanidipine and enalapril as initial treatment of patients with moderate essential hypertension.;Secondary Objective: 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 postdose) after 10 weeks of double-blind treatment. E.
- Secondary Outcome Measures
Name Time Method