Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, 18 to 80 years of age. 2. Patients with a history of essential hypertension; newly diagnosed or patients who have not been treated within 4 weeks of Visit 1 must have an office cuff MSDBP = 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previously treated in an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. 2. 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). 3. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 4. Severe hypertension (an office cuff MSDBP = 110 mmHg and/or MSSBP = 180 mmHg). 5. History or evidence of a secondary form of hypertension. 6. Known Keith-Wagener grade III or IV hypertensive retinopathy. 7. Previous and current diagnosis of heart failure (NYHA Class II-IV). 8. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 9. Serum sodium less than lower limit of normal, serum potassium 8 % at Visit 1. 11. Current angina pectoris requiring pharmacological therapy. 12. Second or third degree heart block without a pacemaker. 13. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1. 14. Clinically significant valvular heart disease. 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. • History of active inflammatory bowel disease during the 12 months prior to Visit 1. • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal 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 during the 12 months prior to Visit 1. • Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT 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 > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine or colestipol resins. 16. History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeut
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Evaluate the efficacy of the combination of aliskiren 300 mg and valsartan 320 mg in patients with essential hypertension by testing the hypothesis of superior reduction in MSDBP from baseline to end of study when compared to both monotherapy components.;Secondary Objective: 1. Evaluate efficacy of combination of aliskiren 300 mg and valsartan 320 mg in patients with essential hypertension by testing superior reduction in mean sitting systolic blood pressure from baseline to end of study when compared to both monotherapy components. 2. Evaluate efficacy of combination of aliskiren 150 mg and valsartan 160 mg in patients with essential hypertension by testing superior reduction in MSDBP and MSSBP from baseline when compared to both monotherapy components at 4 weeks of treatment. 3. Evaluate efficacy of aliskiren 150 mg and 300 mg given alone versus placebo in patients with essential hypertension by testing superior reduction in MSSBP and MSDBP from baseline when compared to placebo. 4. Evaluate safety and tolerability of combination of aliskiren and valsartan (150/160 mg and 300/320 mg) compared with their component monotherapies and placebo. Other secondary objectives listed in the protocol. ;Primary end point(s): The primary efficacy variable is change from baseline (Visit 5) to the end of the study in mean sitting diastolic blood pressure (MSDBP). For each patient, the last post-baseline measurement during the double-blind period will be carried forward to Week 8 as the Week 8 endpoint measurement for the variable to be analyzed. The primary analysis time-point will be the Week 8 endpoint. At each visit, mean sitting diastolic blood pressure is calculated based on the average of the available readings of sitting diastolic blood pressure | — |
Countries
Germany, Spain
Outcome results
None listed