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

Takeda1,090 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,090

Conditions

Hypertension

Interventions

Azilsartan/AmlodipineDRUG

Azilsartan/Amlodipine combination tablets LD \& HD

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (2)

Unnamed facility

Osaka, Japan

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants Who Had One or More Adverse Events

Time frame: Up to Month 12

Secondary Outcomes

Systolic Office Blood Pressure

Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

Time frame: 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.

Time frame: Baseline, Month 1, and final assessment point (up to Month 12)

Data from ClinicalTrials.gov

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