Hypertension MedDRA version: 7.1 Classification code 10020772
Conditions
Interventions
Product Name: aliskiren
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical f
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Outpatients 18 years of age and older. 2.Patients must meet following blood pressure criteria: • At Visit 2: Office MSDBP = 90 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Severe hypertension [Office MSDBP = 110 mmHg and/or office mean sitting systolic blood pressure (MSSBP) = 180 mmHg]. 2.History or evidence of a secondary form of hypertension. 3.Known Keith-Wagener grade III or IV hypertensive retinopathy. 4.History of hypertensive encephalopathy or cerebrovascular accident. 5.Transient ischemic cerebral attack during the 12 months prior to Visit 1. 6.Current diagnosis of heart failure (NYHA Class II-IV). 7.History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 8.Current angina pectoris requiring pharmacological therapy. 9.Second or third degree heart block without a pacemaker. 10.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 11.Clinically significant valvular heart disease. 12.History of Type 1 diabetes or history of Type 2 diabetes and glycosylated hemoglobin (HbA1c) > 8 % at Visit 1. 13.Serum sodium less than the lower limit of normal, serum potassium 1.5 ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. 16.Upper arm circumference > 42 cm. 17.Third shift or night workers. 18.History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. 19.History or evidence of drug or alcohol abuse within the last 12 months. 20.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). 21.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. 22.History of noncompliance to medical regimens or unwillingness to comply with the study protocol. 23.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety. 24.Participation in any investigational drug trial within one month of Visit 1. 25.Persons directly involved in the execution of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Demonstrate the efficacy of aliskiren 300 mg following a missed dose by testing the hypothesis of superior mean 24 hour ambulatory diastolic blood pressure (MADBP) change from baseline compared to irbesartan 300 mg, 2. Demonstrate the efficacy of aliskiren 300 mg following a missed dose by testing the hypothesis of superior mean 24 hour ambulatory diastolic blood pressure (MADBP) change from baseline compared to ramipril 10 mg. ;Secondary Objective: 1. Demonstrate the efficacy of aliskiren 300 mg following a missed dose by testing the hypothesis of superior mean 24 hour ambulatory systolic blood pressure (MASBP) change from baseline compared to ramipril 10 mg as well as irbesartan 300 mg. 2. Demonstrate the efficacy of aliskiren 300 mg following a missed dose by testing the hypothesis of superior daytime and nighttime MASBP and MADBP change from baseline compared to ramipril 10 mg as well as irbesartan 300 mg. 3. Compare the efficacy of aliskiren 300 mg to ramipril 10 mg as well as irbesartan 300 mg on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group. For detailed list of secondary objectives see full protocol ;Primary end point(s): The primary efficacy variable is change from baseline (post-baseline – baseline; baseline is Visit 3) in mean ambulatory 24-hour diastolic blood pressure and the primary analysis time-point is Visit 6 / Visit 7 (i.e., following missed dose). | — |
Countries
Germany, Hungary, Italy, Slovakia, Spain
Outcome results
None listed