Hypertension
Conditions
Interventions
Product Name: Aliskiren
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-58-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharm
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Outpatients = 65 years of age and older. • Male or female patients are eligible. • Patients with essential hypertension. Patients must have an office cuff MSSBP = 140 mmHg and 135 mmHg at Visit 3. • Patients must have an absolute difference of ? 10 mmHg in their mean office cuff sitting systolic blood pressure (MSSBP) during the last two visits (Visit 2 and 3 or the optional Visit 201 and 3) of the single-blind placebo run-in period of the study. • 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following physiological states or concomitant medical conditions at either Visit 1, Visit 2, optional visit 201 or Visit 3 (unless otherwise stated) will be excluded from participation in the study. • Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. • Severe hypertension ( Office MSDBP = 110 mmHg and/or Office MSSBP = 180 mmHg) • History or evidence of a secondary form of hypertension • Known Keith-Wagener grade III or IV hypertensive retinopathy. • History of hypertensive encephalopathy or cerebrovascular accident • Transient ischemic cerebral attack during the 12 months prior to Visit 1. • Current or previous diagnosis of heart failure (NYHA Class II-IV). • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. • Current angina pectoris requiring pharmacological therapy • Second or third degree heart block without a pacemaker. • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. • Clinically significant valvular heart disease. • Type 1 or Type 2 diabetes mellitus with fasting glycosylated hemoglobin (HbA1c) > 8% at Visit 1. • Patients employed as a night shift worker. • Arm circumference 42 cm. • A diagnosis of Atrial Fibrillation • Serum sodium less than the lower limit of normal, serum potassium 1.5 X ULN at Visit 1 [ULN: male = 1.3 mg/dL (115 umol/L), female = 1.2 mg/dL (106 umol/l)], a history of dialysis, or a history of nephrotic syndrome. • History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. • History or evidence of drug or alcohol abuse within the last 12 months. • 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. • History of noncompliance to medical regimens or unwillingness to comply with the study protocol. • Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety. • Participation in any investigational drug trial within one month of Visit 1. • Persons directly involved in the executio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the blood pressure lowering effect for the change from baseline to study endpoint in mean 24-hour systolic ambulatory blood pressure (ABPM) in patients = 65 years of age with essential hypertension, by testing the hypothesis that 300 mg is superior to 75 mg;Secondary Objective: -Evaluate blood pressure lowering effect for change from baseline to study endpoint in mean 24-hour diastolic ambulatory blood pressure in patients = 65 years with essential hypertension, by testing that 300 mg is superior to 75 mg. -Evaluate blood pressure lowering effects of aliskiren in patients = 65 years with essential hypertension for change from baseline to study endpoint in mean sitting systolic and mean sitting diastolic office blood pressure. -Evaluate blood pressure lowering effects of aliskiren in patients = 65 years with essential hypertension for change from baseline to study endpoint in mean day time systolic and diastolic ambulatory blood pressure. -Evaluate blood pressure lowering effects of aliskiren in patients = 65 years with essential hypertension in mean night time systolic and diastolic ambulatory blood pressure. -Compare the blood pressure lowering effects of aliskiren and lisinopril. -Evaluate the safety and tolerability of aliskiren ;Primary end point(s): The primary efficacy variable is change from baseline in mean ambulatory 24-hour systolic blood pressure and the primary analysis time-point is the end of the study. | — |
Countries
Austria, Italy, Sweden
Outcome results
None listed