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

October 28, 2013 updated by: Yoshihiko Saito, Nara Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Office Blood Pressure
Time Frame: Baseline and every 2 weeks (up to 12 weeks)
Change in blood pressure measured at a clinic
Baseline and every 2 weeks (up to 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and every 2 weeks (up to 12 weeks)
Change in Renal Function
Time Frame: Baseline and 12 weeks
Changes in levels of serum creatinine and proteinuria
Baseline and 12 weeks
Change in Fasting Triglyceride
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Glycemic Control
Time Frame: Baseline and 12 weeks
Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
Baseline and 12 weeks
Change in Plasma Aldosterone Concentration
Time Frame: Baseline and 12 weeks
Only in patients with secondary hypertension
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nara Medical University

Investigators

  • Principal Investigator: Yoshihiko Saito, MD, PhD, First Department of Internal Medicine, Nara Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-Ken-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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