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

An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 12 years and older
Conditions the study is for: Hypertension
What is being tested?: T80/A5/H12.5 FDC
How many people: 676 participants
Where: 1 siteJapan
Study dates: 20 Jan 2017to 11 Apr 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 500

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd
Tokyo, 4570047

Other trials in Japan

About this study

Official 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

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

Read the 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.

Conditions: Hypertension
Being tested: T80/A5/H12.5 FDC
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T80/A5/H12.5 FDCDrug
Also called MICATRIO
Drug

Study groups in NCT03021265
Study group	Role	What they receive
T80/A5/H12.5 FDC		Patients with hypertension Receives: Drug: T80/A5/H12.5 FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Patients With Any Suspected Adverse Drug Reactions
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.
Measured: from first intake of Micatrio combination tablet until last intake +1 day (week 52)

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 201711 Apr 2019

First posted13 Jan 2017 (estimated)
Study start20 Jan 2017
Primary completion11 Apr 2019
Study completion11 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 676 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03021265
Sponsor's protocol ID: 1348.6
Status last verified: May 2020
First submitted: 12 Jan 2017
Last updated: 12 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03021265
Acronym / sponsor ID: 1348.6
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 676 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Jan 2017 (actual)
Primary completion: 11 Apr 2019 (actual)
Study completion: 11 Apr 2019 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 12 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
T80/A5/H12.5 FDC	–	Drug: T80/A5/H12.5 FDCPatients with hypertension

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 500

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T80/A5/H12.5 FDCAlso: MICATRIODrug	Drug	T80/A5/H12.5 FDC

Primary outcome

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.

2 secondary outcomes

Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
Time frame: At baseline and week 52
Change From Baseline in Clinic Systolic Blood Pressure at Week 52
Time frame: At baseline and week 52

Results and safety

Results posted to the registry on 12 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micatrio® Combination Tablets	676	554

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Micatrio® Combination Tablets n = 672
Value	32

Population analysed: Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues. 4 patients were excluded because of missing visits after baseline.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from first intake of Micatrio combination tablet until last intake +1 day (week 52). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micatrio	20 of 672 (3%)	0 of 672 (0%)	2 of 672

Limitations and caveats (from the sponsor): The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

Rie Ikeda, +81364172200 study chair

zzCDMJP_PV_PMS@boehringer-ingelheim.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.