Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
2 other identifiers
observational
3,437
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2012
CompletedFirst Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2016
CompletedResults Posted
Study results publicly available
January 15, 2019
CompletedJanuary 15, 2019
July 1, 2018
3.6 years
February 26, 2014
September 25, 2017
July 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Baseline, 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)
Study Arms (1)
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.
Interventions
Eligibility Criteria
Hypertension
You may qualify if:
- Hypertensive patients
You may not qualify if:
- Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
- Patients who are pregnant or having possibilities of being pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (2)
Unknown Facility
Osaka, Japan
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
March 19, 2014
Study Start
June 20, 2012
Primary Completion
January 15, 2016
Study Completion
January 15, 2016
Last Updated
January 15, 2019
Results First Posted
January 15, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share