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Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes " | Clinical Trials | Clareo Health

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

Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

NCT02100319•Takeda

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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).

Exclusion Criteria

•Patients with contraindications to azilsartan

Locations (2)

Osaka, Japan

Tokyo, Japan

Key Dates

Start Date

March 3, 2014

Primary Completion Date

February 29, 2016

Completion Date

February 29, 2016

Last Updated

March 21, 2019

Enrollment

387

ACTUAL participants

Conditions

Hypertension

Interventions

Azilsartan

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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