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

NCT ID: NCT01609959

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

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.

Conditions

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Hypertension

Keywords

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Hypertension Angiotensin II Receptor Blocker Azilsartan Valsartan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azilsartan group

Group Type ACTIVE_COMPARATOR

Azilsartan

Intervention Type DRUG

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

Valsartan group

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

Valsartan 160 mg per day

Interventions

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Azilsartan

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

Intervention Type DRUG

Valsartan

Valsartan 160 mg per day

Intervention Type DRUG

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nara Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yoshihiko Saito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshihiko Saito, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Internal Medicine, Nara Medical University

Locations

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First Department of Nara Medical University

Kashihara, Nara, Japan

Site Status

Countries

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Japan

Other Identifiers

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12-Ken-001

Identifier Type: -

Identifier Source: org_study_id