E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 compare the efficacy of aliskiren 300 mg qd to aliskiren 150 mg bid in reducing 24-hour mean ambulatory diastolic blood pressure (MADBP) from baseline to the end of period 2 (week 6) of the study in patients with essential hypertension. |
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E.2.2 | Secondary objectives of the trial |
For full list, please refer to protocol.
- To evaluate the efficacy of aliskiren 300 mg qd compared to aliskiren 150 mg bid in reducing mean ambulatory diastolic blood pressure (MADBP) and mean ambulatory systolic blood pressure (MASBP) during the last three hours of the 24- hour dosing period as assessed by change from baseline to the end of period 2 (week 6). - To evaluate the efficacy of aliskiren 300 mg qd compared to aliskiren 150 mg bid in reducing 24-hour mean ambulatory systolic blood pressure (MASBP) from baseline to the end of period 2 (week 6). - To evaluate the safety and tolerability profile of aliskiren in all treatment groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female outpatients 18 years of age and older. - Patients with a diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertensive medication within 4 weeks of Visit 1 must have an office cuff msDBP ≥ 100 mmHg and ≤ 110 mmHg at Visit 1. Patients receiving antihypertensive treatment must have a cuff msDBP of ≥ 95 mmHg and ≤ 110 mmHg at Visit 1. - Prior to the randomization, all patients must have an office cuff msDBP ≥ 100 mmHg and ≤ 110 mmHg. 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 (written informed consent). |
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E.4 | Principal exclusion criteria |
For full list, see protocol
Patients with any of the following at Visit 1 or 2 at which the patient will be excluded from participation in the study. 1. Previously treated with aliskiren in the last six months or have previously participated in an aliskiren trial in this development program within the last six months and who qualified to be randomized or enrolled into the active drug treatment period. 2. 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). 3. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 4. Patients with an office cuff blood pressure of msDBP ≥ 112 mmHg and/or msSBP ≥ 200 mmHg 5. History or evidence of a secondary form of hypertension. 6. Previous or current diagnosis of heart failure (NYHA Class II, III and IV). 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 8. Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1. 9. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled as determined by local country criteria. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of antidiabetic medication for at least 4 weeks prior to Visit 1. 10. Current angina pectoris requiring pharmacological therapy (the use of nitrates for the treatment of angina will be allowed). 11. Second or third degree heart block without a pacemaker. 12. Potentially life threatening arrhythmia during the 12 months prior to Visit 1. |
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E.5 End points |
E.5.1 | Primary end point(s) |
change from baseline (Visit 2) in the mean ambulatory 24-hour diastolic blood pressure (MADBP) and the primary analysis time point is Visit 3 (week 6) endpoint. |
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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) | No |
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 | 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 | 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 | 38 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 51 |
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 | 1 |
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 | 1 |