Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-03

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice

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Detailed Description

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This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice.

Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant's age and condition. The maximum daily dose is 40 mg.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Azilsartan at a dose of 20 to 40 mg, orally, once daily

Azilsartan tablets

Azilsartan

Intervention Type DRUG

Azilsartan tablets

Interventions

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Azilsartan

Azilsartan tablets

Intervention Type DRUG

Other Intervention Names

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Azilva Tablets

Eligibility Criteria

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Inclusion Criteria

* Patients with hypertension who meet all the following criteria will be enrolled:

1. Patients who has complications of diabetes mellitus
2. Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1\* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
3. Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
4. Patients who is an outpatient
5. Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.

\*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).