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: 150-
Pro
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age and older. 2. Patients with essential hypertension. Patients must have 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 enrolled in an aliskiren study and who qualified to be randomized into the active drug treatment period. 2. Severe hypertension (grade 3 WHO classification; 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 within 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) within 6 months prior to Visit 1. 9. Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates). 10. Second or third degree heart block without a pacemaker. 11. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 12. Clinically significant valvular heart disease. 13. Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 9% at Visit 1. 14. Serum sodium less then the lower limit of normal, serum potassium less than 3.5 mEq/L or = 5.2 mEq/L, or dehydration at Visit 1. 15. 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/AST or SGPT/ALT 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 > 1.7 mg/dL (corresponding to 150 ?mol/L) for women and serum creatinine > 2.0 mg/dL (corresponding to 177 ?mol/L) for men at Visit 1, a history of dialysis, or a history of nephrotic syndrome •Current treatment with cholestyramine or cholestipol resins 16. History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years. 17. History or evidence of drug or alcohol abuse within the last 12 months. 18. Pregnant or nursing women. 19. 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. 20. Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drugs. 21. History of gouty arthritis. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of an aliskiren based antihypertensive regimen (aliskiren 150 mg, aliskiren 300 mg, aliskiren 300 mg with HCTZ 12.5 mg/25 mg) when compared to a ramipril based antihypertensive regimen (ramipril 5 mg, ramipril 10 mg, ramipril 10 mg with HCTZ 12.5 mg/25 mg) by testing: (i) the hypothesis of non-inferiority for the aliskiren regimen versus the ramipril regimen on reduction in MSDBP from baseline and (ii) the hypothesis of superiority for the aliskiren regimen versus the ramipril regimen on reduction in MSDBP from baseline, if the hypothesis of non-inferiority is achieved. ;Secondary Objective: •Evaluate efficacy of an aliskiren based antihypertensive regimen when compared to a ramipril based antihypertensive regimen by testing: the hypothesis of non-inferiority for aliskiren regimen versus ramipril regimen on reduction in MSSBP from baseline and hypothesis of superiority for aliskiren regimen versus ramipril regimen on reduction in MSSBP from baseline, if hypothesis of non-inferiority is achieved. •Demonstrate efficacy of an aliskiren based antihypertensive regimen by testing hypothesis of superiority on change in MSDBP and MSSBP from Week 26, after a 4 week randomized, double-blind, placebo-controlled withdrawal period when compared to placebo. •Compare efficacy of aliskiren 150 mg to ramipril 5 mg in reduction of MSDBP and MSSBP from baseline at Week 6. •Compare efficacy of aliskiren 300 mg to ramipril 10 mg in reduction of MSDBP and MSSBP from baseline at Week 12. ;Primary end point(s): The primary efficacy variable is the change from baseline (Visit 3) in the mean sitting diastolic blood pressure (MSDBP), defined as post-baseline value minus baseline value. The primary time point for efficacy analysis will be at the end of the double-blind active-controlled treatment period (Week 26). | — |
Countries
Belgium, Denmark, Iceland, Slovakia, Spain
Outcome results
None listed