Hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100A
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-58-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Novartis Farmacéutuca, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age and older. 2. Male or female patients are eligible. 3. Patients with a diagnosis of hypertension: • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a MSDBP = 100 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. Patients currently on antihypertensive medication(s) that require tapering of > 7 days at Visit 1. 5. Severe hypertension (an office cuff MSDBP = 110 mmHg and/or MSSBP = 180 mmHg). 6. History or evidence of a secondary form of hypertension. 7. Known Keith-Wagener grade III or IV hypertensive retinopathy. 8. Previous or current diagnosis of heart failure (NYHA Class II-IV). 9. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 10. Serum sodium 8.0 % at Visit 1. 13. Current angina pectoris requiring pharmacological therapy. 14. Second or third degree heart block without a pacemaker. 15. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1. 16. Clinically significant valvular heart disease. 17. 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: ALT or AST 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the combination of aliskiren / valsartan / HCTZ (300/320/25 mg) has superior efficacy compared to the combinations of aliskiren / HCTZ (300/25 mg) and valsartan / HCTZ (320/25 mg) in reducing MSDBP from baseline to the end of 8 weeks of treatment in patients with hypertension not adequately responsive to HCTZ 25 mg.;Secondary Objective: 1. To evaluate whether the combination of aliskiren / valsartan / HCTZ (300/320/25 mg) has superior efficacy compared to the combinations of aliskiren / HCTZ (300/25 mg) and valsartan / HCTZ (320/25 mg) in reducing MSSBP from baseline to the end of 8 weeks of treatment in patients with hypertension not adequately responsive to HCTZ 25 mg. 2. To evaluate whether the combination of aliskiren / HCTZ (300/25 mg) has superior efficacy compared to HCTZ alone in reducing MSDBP and MSSBP from baseline to the end of 8 weeks of treatment in patients with hypertension not adequately responsive to HCTZ 25 mg. 3. To evaluate whether the combination of aliskiren / valsartan / HCTZ (150/160/25 mg) has superior efficacy compared to the combinations of aliskiren / HCTZ (150/25 mg) and valsartan / HCTZ (160/25 mg) in reducing MSDBP and MSSBP from baseline to the end of 4 weeks of treatment in patients with hypertension not adequately responsive to HCTZ 25 mg. For detailed list see full protocol;Primary end point(s): The primary efficacy variable is the change from baseline (Visit 4) in mean sitting diastolic blood pressure (MSDBP). | — |
Countries
Germany, Spain
Outcome results
None listed