Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
601
Investigative Centers
San Diego, California, United States
Investigative Centers
Canada, Canada
Investigative Centers
Germany, Germany
Investigative Centers
Netherlands, Netherlands
Overall Percentage of Patients With Adverse Events
Time frame: Month 12
Overall Percentage of Patients With Adverse Events
adverse event data obtained from both the core study and the 6 month extension study.
Time frame: Month 18
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure.
Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Time frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure
Time frame: Baseline and Month 18
Change From Baseline in Mean Sitting Systolic Blood Pressure
Time frame: Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Time frame: Month 18
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