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.
- Conditions
- Essential hypertensionMedDRA version: 12.0Level: LLTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2009-015988-13-DE
- Lead Sponsor
- Recordati S.p.A.,
- 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: 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.
- Secondary Outcome Measures
Name Time Method