Skip to main content
OpenTrials
Completed

NCT Number: NCT01609959

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Department of Nara Medical University

Kashihara, Nara, 634-8522, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azilsartan

Drug

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

valsartan

Drug

Valsartan 160 mg per day

Primary outcomes

  1. Change in Office Blood Pressure

    Time frame: Baseline and every 2 weeks (up to 12 weeks)

    Change in blood pressure measured at a clinic

Secondary outcomes

  1. Change in Home Blood Pressure

    Time frame: 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.

  2. Change in Renal Function

    Time frame: Baseline and 12 weeks

    Changes in levels of serum creatinine and proteinuria

  3. Change in Fasting Triglyceride

    Time frame: Baseline and 12 weeks

  4. Change in Glycemic Control

    Time frame: Baseline and 12 weeks

    Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)

  5. Change in Plasma Aldosterone Concentration

    Time frame: Baseline and 12 weeks

    Only in patients with secondary hypertension

Sponsors and collaborators

Lead sponsor

Nara Medical University

Other

Registry information

Official study title

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

Acronym: NARA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 1, 2012
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.