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

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ClinicalTrials.gov Identifier: NCT01609959
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan Drug: Valsartan Phase 4

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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yoshihiko Saito, Professor, Nara Medical University
ClinicalTrials.gov Identifier: NCT01609959     History of Changes
Other Study ID Numbers: 12-Ken-001
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Yoshihiko Saito, 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
Angiotensinogen
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors