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

Nara Medical University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Azilsartan; Drug: Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01609959

12-Ken-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Azilsartan group

Active Comparator group

Treatment:

Drug: Azilsartan

Valsartan group

Active Comparator group

Treatment:

Drug: Valsartan