A 12 week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg compared to aliskiren 300 mg in patients with Stage II hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

Inclusion Criteria

1. Patients must give written informed consent before any assessment is performed.
2. Outpatients =18 years of age.
3. Patients with a diagnosis of Stage II hypertension, defined as msSBP = 160 mmHg and < 180 mmHg at Visit 2.
4. Patients who are eligible, 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
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

For full list, please refer to the protocol.
1. Severe hypertension defined as msSBP = 180 mmHg and/or msDBP = 110 mmHg.
2. History or evidence of secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheocromocitoma).
3. Current diagnosis of heart failure (NYHA Class II-IV).
4. Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
5. Second or third degree heart block without a pacemaker.
6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial
fibrillation or atrial flutter, during the 12 months prior to Visit 1.
7. Clinically significant valvular heart disease.
8. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI).
9. Known Keith-Wagener grade III or IV hypertensive retinopathy.
10. In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications. Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
11. Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down.
12. History of angioedema due to ACE-Is or ARBs administration.
13. Patients with Type 1 diabetes mellitus.
14. Patients with Type 2 diabetes mellitus who are not well controlled based on
investigator’s clinical judgment. Patients currently being treated for diabetes mellitus
must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetic medication must be on a stable dose for at least 4 weeks prior to Visit 1.
15. Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L
(corresponding to 3.5 mmol/L) or = 5.3 mEq/L (corresponding to 5.3 mmol/L), or
dehydration at Visit 1.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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