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 PressureChange 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
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