Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
2 other identifiers
observational
1,090
1 country
2
Brief Summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) \& High Dose (HD) (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice.
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 2014
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2014
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2017
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedJune 3, 2019
February 1, 2019
2.6 years
July 2, 2014
August 24, 2018
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Had One or More Adverse Events
Up to Month 12
Secondary Outcomes (2)
Systolic Office Blood Pressure
Baseline, Month 1, and final assessment point (up to Month 12)
Diastolic Office Blood Pressure
Baseline, Month 1, and final assessment point (up to Month 12)
Study Arms (1)
Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
Interventions
Azilsartan/Amlodipine combination tablets LD \& HD
Eligibility Criteria
Hypertension
You may qualify if:
- Hypertensive patients
You may not qualify if:
- Hypertensive patients who meet any of the following conditions, \[1\] to \[3\], are excluded from the survey:
- Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
- Patients who are pregnant or having possibilities of being pregnant
- Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
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)
Intervention 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
July 2, 2014
First Posted
July 4, 2014
Study Start
June 26, 2014
Primary Completion
January 31, 2017
Study Completion
January 31, 2017
Last Updated
June 3, 2019
Results First Posted
June 3, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share