New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Azilsartan
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day. Exclusion Criteria: Hypersensitivity for azilsartan and valsartan Pregnant female History of azilsartan use within 3 months
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azilsartan group<br> | Drug: Azilsartan<br>* Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks<br>|
| Active Comparator: Valsartan group<br> | Drug: Valsartan<br>* Valsartan 160 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Blood Pressure | Change in blood pressure measured at a clinic | Baseline and every 2 weeks (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and every 2 weeks (up to 12 weeks) | 
| Change in Renal Function | Changes in levels of serum creatinine and proteinuria | Baseline and 12 weeks | 
| Change in Fasting Triglyceride |  | Baseline and 12 weeks | 
| Change in Glycemic Control | Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed) | Baseline and 12 weeks | 
| Change in Plasma Aldosterone Concentration | Only in patients with secondary hypertension | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Angiotensin II Receptor Blocker, Azilsartan, Valsartan