E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
|
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 compare the BP lowering effect of the combination of aliskiren / HCTZ 300/25 mg versus aliskiren 300 mg monotherapy in patients with Stage II hypertension by testing the hypothesis that the combination of aliskiren / HCTZ produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 12-weeks of treatment. |
|
E.2.2 | Secondary objectives of the trial |
To estimate the BP lowering effect of aliskiren / HCTZ (300/25 mg) combination vs aliskiren (300 mg) monotherapy on the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment. To estimate the BP lowering effect of aliskiren / HCTZ (300/25 mg) combination vs aliskiren (300 mg) monotherapy on the change from baseline in mean sitting diastolic blood pressure (msDBP) after 12 and 8 weeks of treatment. To estimate the change from baseline in mean sitting systolic blood pressure (msSBP) after 12 and 8 weeks of treatment with aliskiren / HCTZ (300/25 mg) combination. To estimate the change from baseline in mean sitting diastolic blood pressure (msDBP) after 12 and 8 weeks of treatment with aliskiren / HCTZ (300/25 mg) combination. To estimate the change from baseline in msSBP after 12 and 8 weeks of aliskiren (300 mg)monotherapy. PLS SEE PROTOCOL |
|
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: valutazione degli indicatori biologici
|
|
E.3 | Principal inclusion criteria |
1. Outpatients &#8805;18 years of age. 2. Patients with a diagnosis of Stage II hypertension, defined as msSBP &#8805; 160 mmHg and < 180 mmHg at Visit 2. |
|
E.4 | Principal exclusion criteria |
1. Severe hypertension defined as msSBP &#8805; 180 mmHg and/or msDBP &#8805; 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. 6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1. 7. Clinically significant valvular heart disease. 8. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI). 9. Known Keith-Wagener grade III or IV hypertensive retinopathy. 10. 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. 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 investigators clinical judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetic medication must be on a stable dose for at least 4 weeks prior to Visit 1. 14. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down. 15. Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or &#8805; 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1. 16. Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following: History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the change from baseline in mean sitting systolic blood pressure (msSBP). The primary analysis time-point will be the Week-12 endpoint. |
|
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 | 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 | 37 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 74 |
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 |
|
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
| |
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 | 11 |
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 | 11 |