Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, 40-75 years of age at screening. 2. Patients with a history of essential hypertension, either drug naïve or under a maximum of two current antihypertensive treatments. 3. Raised blood pressure (MSSBP = 130 mmHg and/or MSDBP = 85 mmHg) at screening and baseline. 4. Central obesity (defined as waist circumference = 102 cm for men and = 88 cm for women). 5. Patients should have either or both of the following: i) Triglyceride levels of = 1.7 mmol/L (150 mg/dL). ii) Fasting plasma glucose (FPG) = 5.6 mmol/L (100.8 mg/dL) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (MSSBP of = 180 mmHg and/or MSDBP of = 110 mmHg). 2. Previous treatment in an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. 3. Current treatment with three or more antihypertensive treatments. 4. Current treatment with hormone replacement therapy (HRT). 5. Smokers. Urine cotinine levels will be measured during screening for all subjects and a smoker will be defined as any subject who has a urine cotinine level > 500 ng/mL. 6. History or evidence of a secondary form of hypertension. 7. Known Keith-Wagener grade III or IV hypertensive retinopathy. 8. History of hypertensive encephalopathy or cerebrovascular accident. 9. Current diagnosis of heart failure (NYHA Class II-IV). 10. History of transient ischemic cerebral attack within the last 12 months. 11. History of myocardial infarction. 12. History of coronary bypass surgery, or any percutaneous coronary intervention (PCI). 13. Serum sodium less than lower limit of normal, serum potassium 5 mIU/mL). • 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. • Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. • Women using hormonal contraception that has not been at a consistent dose for at least 3 months and is not expected to remain at this dose throughout the study . 16. Current angina pectoris requiring pharmacological therapy. 17. Second or third degree heart block without a pacemaker. 18. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 19. Clinically significant valvular heart disease. 20. 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. • Currently active or previously active inflammatory bowel disease during the 12 months prior to screening. • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding durin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of multiple dose administration of aliskiren and irbesartan on systemic biomarkers of inflammation and other markers associated with cardiovascular and/or metabolic disease.;Secondary Objective: • To perform exploratory pharmacogenetic assessments to examine whether individual variation in genes relating to drug metabolism, hypertension, metabolic syndrome, and the renin-angiotensin pathway predict response to aliskiren or irbesartan. . • To conduct exploratory genomic, proteomic and metabonomic studies to identify proteins and metabolites in blood and urine that are associated with treatment response to aliskiren or irbesartan, or that may correlate with baseline disease status. ;Primary end point(s): Pharmacodynamic assessment of the effects of multiple dose administration of aliskiren and irbesartan on systemic biomarkers of inflammation and other markers associated with cardiovascular and/or metabolic disease | — |
Countries
Germany
Outcome results
None listed