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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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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 |
In Phase 1, to evaluate the dose response of aliskiren in msSBP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension. In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msSBP change at end of Phase 2 from the end of Phase 1, compared to placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of short-term (8 weeks) administration of aliskiren in children aged 6 to 17 years with hypertension. In Phase 1, to evaluate the dose response of aliskiren in msDBP and MAP change at end of Phase 1 from the baseline, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension. In Phase 2 (placebo controlled phase), to evaluate pooled treatment effect of aliskiren in msDBP and MAP change at end of Phase 2 from the end of Phase 1, compared to placebo pooled from corresponding arms, as measured by office blood pressure reading, in children 6 to 17 years old with hypertension. To explore the effect of aliskiren at low, mid and high doses on the 24 hour ambulatory blood pressure monitoring (ABPM) profiles. To explore the relationship between change in plasma renin activity (PRA) and the dose of aliskiren, at the end of Phase 1, in children aged 6 to 17 years with hypertension |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female, ages 6 years to 17 years 6 months at randomization, with a documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004 • Must be ≥ 20 kg and ≤ 150 kg at randomization (Visit 2) • Must be able to safely wash out prior antihypertensive therapy for a minimum of 7 days if already receiving treatment • Must be able to swallow minitablets (2mm in diameter) administered in soft food • msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004 • Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent may be required for some patients depending upon their age and local requirements regarding assents.) |
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E.4 | Principal exclusion criteria |
• Renal artery stenosis • History of angioedema • Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease • msSBP ≥ 25% above the 95th percentile • Second or third degree heart block without a pacemaker • Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening, or any symptomatic arrhythmia during the 12 months prior to Visit 1 • Previous solid organ transplantation • Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition • Human immunodeficiency virus (HIV) by history and/or the patient is concomitantly receiving anti-retroviral therapy for the treatment of HIV • Any clinically significant unstable medical condition or chronic disease that would put the patient at risk of experiencing an adverse event associated with the expected pharmacodynamic effects of the study medication • Any surgical or medical condition or concomitant medication which might significantly alter the absorption, distribution, metabolism, or excretion of study medication • Current treatment with atorvastatin, cholestyramine or colestipol resins, monoamine oxidase (MAO) inhibitors, ketoconazole, itraconazole, or antiarrhythmic medications (other than digoxin) • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin • History or evidence of drug or alcohol abuse within the last 12 months • Females of child-bearing potential, defined as all females aged 8 years and above, physiologically capable of becoming pregnant, including women whose lifestyle or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are willing to use an acceptable, hormonal or non-hormonal form of birth control, including for non-hormonal forms of birth control, double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap), or abstinence • Pregnant or nursing (lactating) women • History of hypersensitivity to study medication or to any drug of similar chemical class • Participation in any investigational drug study within 30 days • Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for this long-term study is efficacy and safety. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
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.8.5 | 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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 6 |