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

February 26, 2019 updated by: Takeda

Azilsartan/Amlodipine (Zacras) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1090

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hypertension

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets LD & HD
Other Names:
  • Zacras Combination Tablets LD & HD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 1, and final assessment point (up to Month 12)
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.
Baseline, Month 1, and final assessment point (up to Month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2014

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 4, 2014

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212-011
  • JapicCTI-142592 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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