The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
532
Aliskiren 150 mg or 300 mg taken once daily in oral form
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline and Week 8
Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: 8 weeks
Percentage of Participants With Blood Pressure Response at Week 8
Response is defined as a patient with msSBP \< 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.
Time frame: 8 weeks
Percentage of Patients Achieving Blood Pressure Control at Week 8
Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure \< 140/90 mmHg.
Time frame: 8 weeks
Change From Baseline to Week 8 in Pulse Pressure
Time frame: Baseline and Week 8
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