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 | 9.1 |
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 |
Confirm the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to study end when compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (msDBP) from baseline to study end when compared to placebo. Evaluate the effect of aliskiren 75 mg, 150 mg, 300 mg and placebo on the change from baseline in mean 24 hour ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients Evaluate the effect of aliskiren 75 mg, 150 mg, 300 mg and placebo on the smoothness index, trough to peak ratio and morning surge of ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients Evaluate the proportion of patients achieving blood pressure response rate as defined by msSBP < 140 mmHg and/or a ≥ 20 mmHg decrease in msSBP from baseline to end of study. Evaluate the safety and tolerability of aliskiren 75 mg, 150 mg and 300 mg. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: BIOPMARKERS ''OPTIONAL''
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E.3 | Principal inclusion criteria |
Male and female outpatients 65 years of age and older. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period. |
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E.4 | Principal exclusion criteria |
Severe hypertension [Office msDBP ≥ 110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg]. History or evidence of a secondary form of hypertension. Known Keith-Wagener grade III or IV hypertensive retinopathy. History of hypertensive encephalopathy or cerebrovascular accident including a history of transient ischemic cerebral attack (TIA). Current diagnosis of heart failure (NYHA Class II-IV). History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). Current angina pectoris requiring pharmacological therapy other than nitrates. Second or third degree heart block without a pacemaker. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. Clinically significant valvular heart disease at the discretion of the principal investigators clinical judgment. History of Type 1 diabetes, or Type 2 diabetes and glycosylated hemoglobin (HbA1c) > 8 % at Visit 1. Serum potassium ≥ 5.5 mEq/L at Visit 1. Estimated glomerular filtration rate (GFR) < 45 mL/min/1.73 m2 using the MDRD formula at Visit 1. Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. Previous participation in an investigational clinical trial within 1 month of Visit 1. Previous exposure to aliskiren within 3 months of Visit 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test (> 5 mIU/ml). Women of child-bearing potential,PLEASE SEE PROTOCOL |
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E.5 End points |
E.5.1 | Primary end point(s) |
Confirm the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to study end when compared to placebo. |
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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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 130 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |