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

Information source: Nara Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Azilsartan (Drug); Valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nara Medical University

Official(s) and/or principal investigator(s):
Yoshihiko Saito, MD, PhD, Principal Investigator, Affiliation: First Department of Internal Medicine, Nara Medical University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Office Blood Pressure

Secondary outcome:

Change in Home Blood Pressure

Change in Renal Function

Change in Fasting Triglyceride

Change in Glycemic Control

Change in Plasma Aldosterone Concentration

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

First Department of Nara Medical University, Kashihara, Nara 634-8522, Japan
Additional Information

Starting date: June 2012
Last updated: October 28, 2013

Page last updated: August 23, 2015

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