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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Azilsartan/Amlodipine

Drug

Azilsartan/Amlodipine combination tablets LD & HD

Other names: Zacras Combination Tablets LD & HD

Primary outcomes

Percentage of Participants Who Had One or More Adverse Events

Time frame: Up to Month 12

Secondary outcomes

Systolic Office Blood Pressure

Time frame: 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.
Diastolic Office Blood Pressure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jul 4, 2014
Registry last updated: Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed