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

Completed

• Conditions: Hypertension
• Interventions: Drug: Azilsartan/Amlodipine

• Registration Number: NCT02181816
• Lead Sponsor: Takeda

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.

Detailed Description

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 Timeline

• Study Start: 2014-06-26
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Results First Submitted: 2018-08-24
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Results First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1090

Inclusion Criteria

-Hypertensive patients

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilsartan/Amlodipine	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had One or More Adverse Events	Up to Month 12

Secondary Outcome Measures

Name	Time	Method
Diastolic Office Blood Pressure	Baseline, Month 1, and final assessment point (up to Month 12)	Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Systolic Office Blood Pressure	Baseline, Month 1, and final assessment point (up to Month 12)	Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.