| 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 |
| Evaluate the efficacy of the combination of aliskiren 300 mg and atenolol 100 mg in patients with essential hypertension by testing the hypothesis of superior reduction in MSDBP from baseline when compared to both monotherapy components after 12 weeks of treatment. |
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| E.2.2 | Secondary objectives of the trial |
•Evaluate efficacy of combination of aliskiren 300 mg and atenolol 100 mg in patients with essential hypertension by testing superior reduction in MSSBP from baseline when compared to both monotherapy components after 12 wks of treatment.
•Evaluate efficacy of the combination of aliskiren 150 mg and atenolol 50 mg in patients with essential hypertension by testing superior reduction in MSDBP and MSSBP from baseline when compared to both monotherapy components after 6 wks of treatment.
•Compare efficacy of aliskiren 300 mg with atenolol 100 mg in patients with essential hypertension in reduction of MSDBP and MSSBP from baseline after 12 wks of treatment.
•Compare efficacy of aliskiren 150 mg with atenolol 50 mg in patients with essential hypertension in reduction of MSDBP and MSSBP from baseline after 6 wks of treatment.
•Evaluate and compare safety and tolerability of aliskiren, atenolol and the combination of aliskiren and atenolol in patients with essential hypertension.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
•Outpatients 18 years of age and older.
•Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
•Patients with essential hypertension.
•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).
To be eligible for randomization into the double-blind treatment period at Visit 3, patients must also fulfill the following criteria:
• Patients must have a MSDBP 90 mmHg and < 110 mmHg at Visit 2 or optional Visit 201, and a MSDBP 95 mmHg and < 110 mmHg at Visit 3 (Day 1).
• Patients must have an absolute difference in their MSDBP ≤ 10 mmHg during the last two visits (Visit 2 and 3 or the optional visit 201 and 3) of the single-blind run-in period.
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| E.4 | Principal exclusion criteria |
1. Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
2. Severe hypertension (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 180 mmHg)
3. History or evidence of a secondary form of hypertension
4. Known Keith-Wagener grade III or IV hypertensive retinopathy.
5. History of hypertensive encephalopathy or cerebrovascular accident
6. Transient ischemic cerebral attack during the 12 months prior to Visit 1.
7. Current diagnosis of heart failure (NYHA Class II-IV).
8. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1.
9. Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates)
10. Second or third degree heart block without a pacemaker.
11. Sinus bradycardia (heart rate less than 55 bpm).
12. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
13. History of sick sinus syndrome.
14. Clinically significant valvular heart disease.
15. Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9% at Visit 1.
16. History of bronchospasm, asthma or chronic obstructive pulmonary disease.
17. Symptomatic peripheral artery disease.
18. Serum sodium less than the lower limit of normal, serum potassium <3.5 mEq/L or ≥ 5.5 mEq/L, or dehydration at Visit 1.
19. Any 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.
• Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1.
• Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
• Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
• Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
• Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 times the upper limit of normal at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
• Current treatment with cholestyramine and colestipol resins.
20. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
21. History or evidence of drug or alcohol abuse within the last 12 months.
22. Pregnant or nursing women.
23. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
24. Known or suspected contraindications to the study medications including history of allergy to atenolol or other β-blockers.
25. History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
26. Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
27. Participation in any investigational drug study within one month of Visit 1.
28. Persons directly involved in the execution of this protocol
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| change from baseline (Visit 3) in mean sitting diastolic blood pressure. The primary analysis timepoint will be the Week 12 (Visit 8) endpoint. For each patient, the last post-baseline measurement during the double-blind period will be carried forward to Week 12 as the Week 12 endpoint measurement for the variable to be analyzed. |
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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 | Yes |
| 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 | Yes |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | No |
| 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) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Information not present in EudraCT |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| 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 | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
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