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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015488 |
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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 |
To demonstrate the efficacy of a valsartan treatment strategy compared to an amlodipine treatment strategy by testing the hypothesis of non-inferiority in reaching blood pressure control at end of study Visit 6, week 14 as determined by proportion of patients that are controlled. If this can be demonstrated, superiority will be tested between the valsartan treatment strategy group and the amlodipine treatment strategy group |
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E.2.2 | Secondary objectives of the trial |
To evaluate -efficacy of a valsartan compared to amlodipine treatment, for the overall study population, by testing the hypothesis of non-inferiority in reaching blood pressure control at week 4,8 and 11;-efficacy, in each of the two different patient stratum treatment na ve and previously treated and uncontrolled on present monotherapy of a valsartan compared to amlodipine treatment by testing the hypothesis of non-inferiority in reaching blood pressure control at week 4,8,11 and 14 as determined by proportion of patients that are controlled;-time to BP control of the valsartan versus amlodipine treatment strategy in the overall population and in the two strata as determined by proportion of patients that are controlled at each visit;-MSSBP and MSDBP lowering of the valsartan versus amlodipine treatment strategy in the overall population and in the two strata between baseline and week 4,8,11 and 14;-safety and tollerability, measured by rate of adverse event,of the val vs amlod |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Male or female outpatients, age between 18- 75 years of age, inclusive, at Visit 1 -Stage/grade 1 or 2 hypertension, MSSBP maggiore/uguale a 140 mmHg, and/or MSDBP maggiore/uguale a 90 mmHg, at visit 1 and 2 in untreated patients; untreated is defined as treatment naive or patients not treated in the past 12 weeks or patients who are currently treated on monotherapy and uncontrolled and have a blood pressure 8804; 160/100 mmHg at Visit 1 and Visit 2. Treatment is defined as having taken medication until 8804; 2 days prior to Visit 1. Treatment is defined as having taken medication for a minimum of 4 weeks and until 8804; 2 days prior to Visit 1. Patients who neither meet the definition of treated or untreated will not be eligible for study entry. -Written informed consent to participate in the study prior to any study procedures |
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E.4 | Principal exclusion criteria |
-Current treatment with a CCB -MSSBP / 180 mmHg o MSDBP / 110 mmHg at any time between visit1 and visit 2 -history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures -Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyper-aldosteronism, renal artery stenosis, or pheochromocytoma, etc -Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 -Transient ischemic cerebral attack during the last 6 months, prior to Visit 1 -History of/or symptoms consistent with congestive heart failure -Clinically significant valvular heart disease -Second or third degree heart block without a pacemaker -Concomitant angina pectoris -Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia -Diabetes mellitus -Serum potassium 3.5 or 5.5 mmol/L without medication at Visit 1 -Serum creatinine 1.5 ULN at Visit 1 or a history of dialysis or nephrotic syndrome |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate the efficacy of a valsartan treatment strategy compared to an amlodipine treatment strategy by testing the hypothesis of non-inferiority in reaching blood pressure control at end of study Visit 6, week 14 as determined by proportion of patients that are controlled |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | |
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 |