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

Sponsor

Nara Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT01609959

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Azilsartan Drug: Valsartan	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Azilsartan group

Drug: Azilsartan

Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks

Active Comparator: Valsartan group

Drug: Valsartan

Valsartan 160 mg per day

Outcome Measures

Primary Outcome Measures

Change in Office Blood Pressure [Baseline and every 2 weeks (up to 12 weeks)]
Change in blood pressure measured at a clinic

Secondary Outcome Measures

Change in Home Blood Pressure [Baseline and every 2 weeks (up to 12 weeks)]
Change in blood pressure measured at home Blood pressure is measured twice daily in the morning fasting before taking any drugs.
Change in Renal Function [Baseline and 12 weeks]
Changes in levels of serum creatinine and proteinuria
Change in Fasting Triglyceride [Baseline and 12 weeks]
Change in Glycemic Control [Baseline and 12 weeks]
Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
Change in Plasma Aldosterone Concentration [Baseline and 12 weeks]
Only in patients with secondary hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.