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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-26

Study Completion Date

2017-01-31

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.

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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.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Azilsartan/Amlodipine

Intervention Type DRUG

Azilsartan/Amlodipine combination tablets LD \& HD

Interventions

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Azilsartan/Amlodipine

Azilsartan/Amlodipine combination tablets LD \& HD

Intervention Type DRUG

Other Intervention Names

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Zacras Combination Tablets LD & HD

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:

1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
2. Patients who are pregnant or having possibilities of being pregnant
3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

Eligible Sex

ALL

Accepts Healthy Volunteers

No