To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension

May 7, 2020 updated by: Boehringer Ingelheim

The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension

Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study.

All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.

Study Type

Observational

Enrollment (Actual)

676

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
      • Tokyo, Japan, 4570047
        • Nippon Boehringer Ingelheim Co., Ltd

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

500

Description

Inclusion criteria:

  • Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert
  • Patients who have never been treated with Micatrio® Combination Tablets before enrolment

Exclusion criteria:

Patients who are participating/planned to participate in a clinical trial

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
T80/A5/H12.5 FDC
Patients with hypertension
Drug: T80/A5/H12.5 FDC
Drug
Other Names:
  • MICATRIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Patients With Any Suspected Adverse Drug Reactions
Time Frame: from first intake of Micatrio combination tablet until last intake +1 day (week 52)
An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.
from first intake of Micatrio combination tablet until last intake +1 day (week 52)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
Time Frame: At baseline and week 52
Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52
At baseline and week 52
Change From Baseline in Clinic Systolic Blood Pressure at Week 52
Time Frame: At baseline and week 52
Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52
At baseline and week 52

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Rie Ikeda, +81364172200, zzCDMJP_PV_PMS@boehringer-ingelheim.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

January 20, 2017

Primary Completion (Actual)

April 11, 2019

Study Completion (Actual)

April 11, 2019

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1348.6

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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