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

NCT ID: NCT03021265

Last Updated: 2020-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

676 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-20

Study Completion Date

2019-04-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T80/A5/H12.5 FDC

Patients with hypertension

T80/A5/H12.5 FDC

Intervention Type DRUG

Drug

Interventions

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T80/A5/H12.5 FDC

Drug

Intervention Type DRUG

Other Intervention Names

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MICATRIO

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Rie Ikeda, +81364172200

Role: STUDY_CHAIR

[email protected]

Locations

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Nippon Boehringer Ingelheim Co., Ltd

Tokyo, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1348.6

Identifier Type: -

Identifier Source: org_study_id

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