Hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
Product Name: Aliskiren
Product Code: SPP100
Sponsors
Novartis Pharma Services Ag
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Outpatients 18 years of age and older. - Male or female patients are eligible. - For newly diagnosed/untreated patients with essential hypertension defined as DBP > 90 and 90 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previously treated in an aliskiren study that contained the treatment group of the combination of aliskiren and valsartan and had been randomized or enrolled into the active drug treatment period of that study. - Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg) - Pregnant or nursing (lactating) women - Women of child-bearing potential (WOCBP) - History or evidence of a secondary form of hypertension - Any history of hypertensive encephalopathy or cerebrovascular accident, or history within 12 months from visit 1 for transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). - Previous or current diagnosis of heart failure (NYHA Class III –IV) - Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1. - Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator's clinical judgment. Patients with diabetes mellitus enrolled in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of antidiabetic medication for at least 4 weeks prior Visit 1. - Current angina pectoris requiring pharmacological therapy except for nitrates. - Second or third degree heart block without a pacemaker. - Atrial fibrillation or atrial flutter at Visit 1, or potentially life-threatening arrhythmia during the 12 months prior to Visit 1. - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. • History of active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or history of gastrointestinal bleeding during the 3 months prior to Visit 1. • Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x 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 > 1.5x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine or colestipol resins. - History of hypersensitivity to any of the medications or drugs belonging to the similar therapeutic class (ARB's, ACE-I, thiazide diuretics, or other sulfonamide derived drugs) as the study drugs. - History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localize
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg/ valsartan 320 mg in patients with essential hypertension (msDBP > 90 mmHg and 90 mmHg and <110 mmHg) - To evaluate the proportion of patients achieving the blood pressure control target of < 140/90 mmHg at the end of study. Exploratory objective(s) 1. To explore the effect of long-term treatment with the combination of aliskiren 300 mg/valsartan 320 mg on plasma renin activity (PRA), plasma aldosterone and plasma renin concentration (PRC). ;Primary end point(s): Long term safety | — |
Countries
Germany, Netherlands, Spain
Outcome results
None listed