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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001305-42-NL
• Date of registration: 04/06/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 30/06/2008
• Target sample size: 744
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001305-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, France, Iceland, Italy, Netherlands, Slovakia

Key inclusion & exclusion 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 < 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

hypertension

Intervention(s)

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-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Rasilez
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Rasilez
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Aliskiren
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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.

Secondary ID(s)

CSPP100A2405

2008-001305-42-SK