Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

Completed

• Conditions: Hypertension
• Interventions: Drug: Azilsartan

• Registration Number: NCT02092025
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-06-20
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Primary Completion: 2016-01-15
• Study Completion: 2016-01-15
• Results First Submitted: 2017-09-25
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Results First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3437

Inclusion Criteria

• Hypertensive patients

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilsartan	Azilsartan	Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	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 Outcome Measures

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