The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
451
Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks
Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks
Sites in USA
East Hanover, New Jersey, United States
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4
Time frame: Baseline and Week 4
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4
Time frame: Baseline and Week 4
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8
Time frame: Baseline and Week 8
Percentage of Responders at Week 4 and Week 8
Responders defined as mean sitting Systolic Blood Pressure \< 140 mmHg or reduction of ≥ 20 mmHg from baseline
Time frame: At 4 weeks and 8 weeks
Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8
Blood pressure control defined as mean sitting Systolic Blood Pressure \< 140 mm Hg and mean sitting Diastolic Blood Pressure \< 90 mm Hg
Time frame: At Weeks 4 and 8
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