The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.
Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor. A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
Valsartan 160 mg per day
First Department of Nara Medical University
Kashihara, Nara, Japan
Change in Office Blood Pressure
Change in blood pressure measured at a clinic
Time frame: Baseline and every 2 weeks (up to 12 weeks)
Change in Home Blood Pressure
Change in blood pressure measured at home Blood pressure is measured twice daily in the morning fasting before taking any drugs.
Time frame: Baseline and every 2 weeks (up to 12 weeks)
Change in Renal Function
Changes in levels of serum creatinine and proteinuria
Time frame: Baseline and 12 weeks
Change in Fasting Triglyceride
Time frame: Baseline and 12 weeks
Change in Glycemic Control
Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
Time frame: Baseline and 12 weeks
Change in Plasma Aldosterone Concentration
Only in patients with secondary hypertension
Time frame: Baseline and 12 weeks
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