Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey Long-term Use Survey

Study Overview
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Brief Summary
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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.

Detailed Description
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This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice. For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.

Official Title
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Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey Long-term Use Survey

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Azilsartan/Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Hypertensive patients Exclusion Criteria: -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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azilsartan/Amlodipine<br>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. | Drug: Azilsartan/Amlodipine<br>* Azilsartan/Amlodipine combination tablets LD & HD<br>* Other names: Zacras Combination Tablets LD & HD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Events |  | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Office Blood Pressure | Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. | Baseline, Month 1, and final assessment point (up to Month 12) | 
| Diastolic Office Blood Pressure | Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported. | Baseline, Month 1, and final assessment point (up to Month 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy