The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
Time frame: 52 weeks
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.
Time frame: 52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
Time frame: 52 weeks
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Novartis Investigative Site
Katsushika-ku, Tokyo, Japan
Novartis Investigative Site
Kiyose, Tokyo, Japan
Novartis Investigative Site
Kunitachi, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, Japan
Novartis Investigative Site
Shibuya-ku, Tokyo, Japan
...and 3 more locations