E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015488 |
E.1.2 | Term | Essential hypertension |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 < 140 mmHg or decrease from baseline >=20 mmHg) -Normalization rate (BP < 140/90 mmHg). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Ultima visita dell`ultimo soggetto inserito nella sperimentazione |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |