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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Azilsartan

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 Type: Observational
• Enrollment (Actual): 3437

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertension

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Azilsartan; Azilsartan tablets; Other Names: Azilva Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	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.	Up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point	Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).	Baseline, Month 1 and final assessment (up to 12 Months)
Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point	Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).	Baseline, Month 1 and Final assessment (up to 12 Months)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2012
• Primary Completion (ACTUAL): January 15, 2016
• Study Completion (ACTUAL): January 15, 2016

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (ESTIMATE): March 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacological therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Azilsartan medoxomil
• Other Study ID Numbers: 279-011; JapicCTI-142441 (REGISTRY: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No