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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University
ClinicalTrials.gov Identifier:
NCT01609959
First received: May 30, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Azilsartan
Drug: Valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Nara Medical University:

Primary Outcome Measures:
  • Change in Office Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]
    Change in blood pressure measured at a clinic


Secondary Outcome Measures:
  • Change in Home Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]

    Change in blood pressure measured at home

    Blood pressure is measured twice daily in the morning fasting before taking any drugs.


  • Change in Renal Function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of serum creatinine and proteinuria

  • Change in Fasting Triglyceride [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Glycemic Control [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)

  • Change in Plasma Aldosterone Concentration [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Only in patients with secondary hypertension


Enrollment: 70
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609959

Locations
Japan
First Department of Nara Medical University
Kashihara, Nara, Japan, 634-8522
Sponsors and Collaborators
Nara Medical University
Investigators
Principal Investigator: Yoshihiko Saito, MD, PhD First Department of Internal Medicine, Nara Medical University
  More Information

No publications provided

Responsible Party: Yoshihiko Saito, Professor, Nara Medical University
ClinicalTrials.gov Identifier: NCT01609959     History of Changes
Other Study ID Numbers: 12-Ken-001
Study First Received: May 30, 2012
Last Updated: October 28, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Nara Medical University:
Hypertension
Angiotensin II Receptor Blocker
Azilsartan
Valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin Receptor Antagonists
Angiotensin II
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 16, 2014