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OpenTrials
Completed

NCT Number: NCT03021265

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd

Tokyo, 4570047, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

T80/A5/H12.5 FDC

Drug

Drug

Other names: MICATRIO

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2017
Registry last updated
May 12, 2020

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.

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