Hypertension MedDRA version: 8.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
Product Name: Aliskiren
Product Code: SPP100
Pharmaceutical Form: Tablet
INN or Proposed INN: A
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients 18 years of age and older. 2. Male or female patients are eligible. 3. For newly diagnosed/untreated patients with essential hypertension defined as DBP > 90 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 Protocol 1. Previously treated in an aliskiren study that contained the treatment group of the combination of aliskiren and amlodipine and had been randomized or enrolled into the active drug treatment period of that study. 2. Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg) 3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) 4. 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 blilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception such as surgical sterilization (e.g., bilateral tubal ligation) or hormonal contraception (implantable, patch, oral). Reliable contraception should be maintained throughout the study and for 7 days after study medication discontinuation. 5. History or evidence of a secondary form of hypertension 6. 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). 7. Previous or current diagnosis of heart failure (NYHA Class III-IV). 8. Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1. 9. 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. 10. Current angina pectoris requiring pharmacological therapy except for nitrates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term (6 month and 12 month) safety of the combinations of aliskiren 300mg/ amlodipine 10 mg in patients with essential hypertension ;Secondary Objective: To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/amlodipine in patients with essential hypertension (msDBP > 90 mmHg and <110 mmHg) To evaluate the proportion of patients achieving the blood pressure control target of < 140/90. To evaluate the proportion of patients achieving a response in msDBP (msDBP < 90mmHG or = 10mmHg) decrease from baseline;Primary end point(s): The primary assessment for safety is the reporting of any adverse events and serious adverse events (SAE) including death. Adverse events will be assessed, on overall, by primary system organ class, by preferred term, by maximum severity, by relationship to the trial treatment, and by discontinuation due to adverse events. | — |
Countries
Finland, Germany, Iceland
Outcome results
None listed