hypertension
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Tablet
INN or Proposed INN: aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical Form: Capsule*
I
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age or older 2. Male or female patients are eligible. 3. msDBP & msSBP Requirements: • For newly diagnosed/untreated patients, msDBP = 100 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to the protocol. 1. Inability to discontinue all prior antihypertensive medications safely for a period of 1 to 4 weeks as required by the protocol. 2. Patients on three antihypertensive drugs with msDBP = 110 mmHg and/or msSBP=180 mmHg at Visit 1. 3. Patients on four or more antihypertensive drugs at Visit 1. 4. Patients with an msSBP=200 and msDBP=120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study. 5. 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). 6. 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/mL 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) or hormonal contraception (e.g., implantable, patch, oral). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 7. History or evidence of a secondary form of hypertension. 8. Any history of hypertensive encephalopathy, cerebrovascular accident, heart failure, transient ischemic cerebral attack (TIA), angina pectoris, myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI). 9. Serum potassium <3.5 mEq/L (mmol/L) or =5.5 mEq/L at Visit 1. 10. Patients Type 2 diabetes mellitus (DM) who are not well controlled based on the investigator's clinical judgment. Patients with Type 2 DM enrolled in this study should be well controlled. It is recommended that patients currently being treated for Type 2 DM be on a stable dose of oral antidiabetic medication for at least 4 weeks prior to Visit 1. Type 1 DM patients are excluded. 11. Second or third degree heart block with or without a pacemaker, or other potentially lifethreatening or symptomatic arrhythmia current or by history. 12. Atrial fibrillation or atrial flutter during the screening period. 13. Clinically significant valvular heart disease. 14. 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 GI 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. • Current treatment with cholestyramine or colestipol resins. 15. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long term safety of the combination of aliskiren / amlodipine / hydrochlorothiazide in patients with essential hypertension over 28 week to 54 weeks of treatment.;Secondary Objective: • To assess the long-term blood pressure lowering (msDBP and msSBP) efficacy of the combination of aliskiren / amlodipine / hydrochlorothiazide in patients with essential hypertension • To evaluate the proportion of patients achieving the blood pressure control target of < 140/90 mmHg at the end of the study. • To evaluate the proportion of patients achieving a response in mean sitting diastolic blood pressure (msDBP < 90 mmHg or a = 10 mmHg decrease from baseline) and mean sitting systolic blood pressure (msSBP < 140 mmHg or a = 20 mmHg decrease from baseline) at the end of study.;Primary end point(s): The primary assessment for safety is the reporting of any adverse events and serious adverse events (SAE) including death, discontinuations due to adverse events, and abnormal laboratory data. | — |
Countries
Belgium, Germany, Slovakia, Spain
Outcome results
None listed