hypertension
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female outpatients 65 years of age and older. 2. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). 3. At the randomization Visit patients must have an office msSBP greater than or equal to 150 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe hypertension [Office msDBP =110 mmHg and/or mean sitting systolic blood pressure (msSBP) = 180 mmHg]. 2. History or evidence of a secondary form of hypertension. 3. Known Keith-Wagener grade III or IV hypertensive retinopathy. 4. History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA). 5. Current diagnosis of heart failure (NYHA Class II-IV). 6. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 7. Current angina pectoris requiring pharmacological therapy other than nitrates. 8. Second or third degree heart block without a pacemaker. 9. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 10. Clinically significant valvular heart disease at the discretion of the principal investigator’s clinical judgment. 11. History of Type 1 diabetes, or Type 2 diabetes and glycosylated hemoglobin (HbA1c) > 8% at Visit 1. 12. Serum potassium = 5.5 mEq/L at Visit 1. 13. Estimated glomerular filtration rate (GFR) 5 mIU/ml). 20. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are: • women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner • women whose partners have been sterilized by vasectomy or other means • using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs), Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable Reliable contraception should be maintained throughout the study and for 14 days after study drug discontinuation. Woman are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Additional exclusion criteria for patients in ambulatory blood pressure measurement substudy: 21. Upper arm circumference > 42 cm. 22. Third shift or night workers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm the efficacy of aliskiren 75 mg, 150 mg and 300 mg in elderly patients with essential hypertension when given with a light meal by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to end of study when compared to placebo.;Secondary Objective: Evaluate the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (msDBP) from baseline to study end when compared to placebo. • Evaluate the effect of aliskiren 75 mg, 150 mg, 300 mg and placebo on the change from baseline in mean 24 hour ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients • Evaluate the effect of aliskiren 75 mg, 150 mg, 300 mg and placebo on the smoothness index, trough to peak ratio and morning surge of ambulatory systolic blood pressure and ambulatory diastolic blood pressure in a subset of patients • Evaluate the proportion of patients achieving blood pressure response rate as defined by msSBP < 140 mmHg and/or a = 20 mmHg decrease in msSBP from baseline to end of study. • Evaluate the safety and tolerability of aliskiren 75 mg, 150 mg and 300 mg.;Primary end point(s): The primary efficacy variable will be the change from baseline in trough mean sitting systolic blood pressure (msSBP) and the primary analysis time-point will be Week 8 Endpoint. | — |
Countries
Czech Republic, France, Iceland, Italy, Netherlands, Slovakia
Outcome results
None listed