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 | 10020772 |
E.1.2 | Term | 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 |
To demonstrate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour mean ambulatory systolic blood pressure (MASBP) from the end of the active treatment period to day 7 of the treatment interruption period. |
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E.2.2 | Secondary objectives of the trial |
Key secondary objectives are listed below. For full list, please refer to the protocol.
1. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour mean ambulatory diastolic blood pressure (MADBP) from the end of the active treatment period to day 7 of the treatment interruption period. 2. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour MASBP and MADBP from baseline to day 7 of the treatment interruption period. 3. To estimate the prolonged efficacy of aliskiren 300 mg compared to telmisartan 80 mg on the change in 24-hour MASBP and MADBP as measured in the last 4 hours from: a) baseline to the end of the active treatment period; b) baseline to day 7 of the treatment interruption period; c) from the end of active treatment to day 7 of the treatment interruption period (morning surge). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Outpatients 18 years of age and older. 2. Patients with a diagnosis of essential hypertension who meet the following BP criteria at Visit 2: • Office msSBP ≥ 140 mmHg and < 180 mmHg before application of ABPM; • Twenty-four hour MASBP ≥ 135 mmHg. 3. Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 4. 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 consent must give written informed consent before any assessment is performed. |
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E.4 | Principal exclusion criteria |
For full list, please refer to the protocol.
1. Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg. 2. History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheocromocitoma). 3. Current diagnosis of heart failure (NYHA Class II-IV). 4. Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates). 5. Second or third degree heart block without a pacemaker and clinically significant valvular heart disease. 6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1. 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI). 8. Known Keith-Wagener grade III or IV hypertensive retinopathy. 9. In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications. Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications. 10. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down. 11. History of angioedema due to ACE-Is or ARBs administration. 12. Patients with Type 1 diabetes mellitus. 13. Patients with Type 2 diabetes mellitus who are not well controlled based on investigator’s clinical judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control and be on a stable dose of antidiabetic medications for at least 4 weeks prior to Visit 1. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the change in 24-hour mean ambulatory systolic blood pressure (24-hour MASBP) over the 7 days treatment interruption period, that is, the change in 24-hour MASBP from end of active treatment to day 7 of treatment interruption. |
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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 | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
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) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 56 |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 20 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 20 |