Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

About this study

This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.

The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hypertensive patients

Exclusion criteria

Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
Patients who are pregnant or having possibilities of being pregnant

Treatment and study plan

Azilsartan

Drug

Azilsartan tablets

Other names: Azilva Tablets

Primary outcomes

Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

Time frame: Up to 12 Months

ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Secondary outcomes

Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point

Time frame: Baseline, Month 1 and final assessment (up to 12 Months)

Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).
Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point

Time frame: Baseline, Month 1 and Final assessment (up to 12 Months)

Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 19, 2014
Registry last updated: Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed