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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan; Drug: Azilsartan

• Registration Number: NCT01609959
• Lead Sponsor: Nara Medical University

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.

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 Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Primary Completion: 2013-09
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan group	Valsartan	-
Azilsartan group	Azilsartan	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Fasting Triglyceride	Baseline and 12 weeks
Change in Renal Function	Baseline and 12 weeks	Changes in levels of serum creatinine and proteinuria
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
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.

Trial Locations

Locations (1)

First Department of Nara Medical University; 🇯🇵 Kashihara, Nara, Japan