This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
253
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
Investigative Site
Bolíva, Venezuela
Investigative Site
Carabobo, Venezuela
Investigative Site
Caracas, Venezuela
Investigative Site
Edo Zulia, Venezuela
Investigative Site
Estado Monagas, Venezuela
Investigative Site
Falcón, Venezuela
Investigative Site
Maracaibo Estado Zulia, Venezuela
The proportion of patients in whom BP control was achieved at the study end point
Time frame: 16 weeks
The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point
Time frame: 8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
Time frame: 16 weeks
Change in msSPA and msDBP from baseline to different time points
Time frame: 4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points
Time frame: 4,8,12 and 16 weeks
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