An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light meal

• Conditions: hypertension

• Registration Number: EUCTR2008-001305-42-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-26
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 744

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 < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15
mmHg difference during the last two visits of the single blind run-in period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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) < 45 mL/min/1.73 m2 using the MDRD
formula at Visit 1.
14. Known or suspected contraindications to the study medications, including history of
allergy to ACE-Inhibitors or ARBs.
15. Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism, or excretion of study drugs.
16. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer)
within the past five years.
17. Previous participation in an investigational clinical trial within 1 month of Visit 1
18. Previous exposure to aliskiren within 3 months of Visit 1
19. 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).
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified