Hypertension
Conditions
Sponsors
Novartis Farmacéutica S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 ß-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •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. ;Main Objective: 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.;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. | — |
Countries
Germany, Spain
Outcome results
None listed