J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation

An observational study of Hypertension, run by Boehringer Ingelheim.

Completed

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

Trial summary

The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following: 1. Adverse events and adverse drug reactions under long-term use 2. Read more about this study

Who is it for?: Ages 20 to 100 years
Conditions the study is for: Hypertension
What is being tested?: Telmisartan
Type of treatment: Pill or oral medicine
How many people: 21,471 participants
Where: No sites listed yet
Study dates: Apr 2006to Jun 2010
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 20 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Japanese hypertension patients

Who may be able to join

Hypertension patients unadministered Micardis.

Who cannot join

Patients with a history of hypersensitivity to any ingredient of this product.
Pregnant woman or possibly pregnant woman
Patients with extremely poor bile secretion or patients with serious hepatic disorder

About this study

Official title: Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)

Adverse events and adverse drug reactions under long-term use
Blood pressure measurements during the survey period
Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events

Conditions: Hypertension
Being tested: Telmisartan
Medical subject headings: Hypertension

What participants receive

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

TelmisartanDrug
Oral administration

Study groups in NCT00659581
Study group	Role	What they receive
Patients with hypertension		Not described Receives: Drug: Telmisartan

What is being measured

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

Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Measured: 3 years after initiation of treatment

Secondary outcomes (8)

Change From Baseline in Systolic Blood Pressure at 6 Months
Measured: initiation and 6 months
Change From Baseline in Diastolic Blood Pressure at 6 Months
Measured: initiation and 6 months
Change From Baseline in Systolic Blood Pressure at 12 Months
Measured: initiation and 12 months
Change From Baseline in Diastolic Blood Pressure at 12 Months
Measured: initiation and 12 months
Change From Baseline in Systolic Blood Pressure at 24 Months
Measured: initiation and 24 months
Change From Baseline in Diastolic Blood Pressure at 24 Months
Measured: initiation and 24 months
Change From Baseline in Systolic Blood Pressure at 36 Months
Measured: initiation and 36 months
Change From Baseline in Diastolic Blood Pressure at 36 Months
Measured: initiation and 36 months

Timeline

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

Apr 2006Jun 2010

First posted16 Apr 2008 (estimated)
Study startApr 2006
Primary completionJun 2010

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: Case only
Time perspective: Prospective
Enrolment: 21,471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659581
Sponsor's protocol ID: 502.511
Status last verified: Jul 2016
First submitted: 11 Apr 2008
Last updated: 25 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

Active, not recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)
ClinicalTrials.gov ID: NCT00659581
Acronym / sponsor ID: 502.511
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 21,471 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jun 2010 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 20 Mar 2012

Clinical summary

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

Adverse events and adverse drug reactions under long-term use
Blood pressure measurements during the survey period
Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with hypertension	–	Drug: Telmisartan

Who may qualify

Ages: 20 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Japanese hypertension patients

Key inclusion criteria (1 listed)

Hypertension patients unadministered Micardis.

Key exclusion criteria (3 listed)

Patients with a history of hypersensitivity to any ingredient of this product.
Pregnant woman or possibly pregnant woman
Patients with extremely poor bile secretion or patients with serious hepatic disorder

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
TelmisartanOral administration	Drug	Patients with hypertension

Primary outcome

Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Time frame: 3 years after initiation of treatment

8 secondary outcomes

Change From Baseline in Systolic Blood Pressure at 6 Months
Time frame: initiation and 6 months
Change From Baseline in Diastolic Blood Pressure at 6 Months
Time frame: initiation and 6 months
Change From Baseline in Systolic Blood Pressure at 12 Months
Time frame: initiation and 12 months
Change From Baseline in Diastolic Blood Pressure at 12 Months
Time frame: initiation and 12 months
Change From Baseline in Systolic Blood Pressure at 24 Months
Time frame: initiation and 24 months
Change From Baseline in Diastolic Blood Pressure at 24 Months
Time frame: initiation and 24 months
Change From Baseline in Systolic Blood Pressure at 36 Months
Time frame: initiation and 36 months
Change From Baseline in Diastolic Blood Pressure at 36 Months
Time frame: initiation and 36 months

Results and safety

Results posted to the registry on 20 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telmisartan	20,994	12,412

Primary outcome: Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events

Time frame: 3 years after initiation of treatment. Number. Unit: Number of participants

Measure	Telmisartan n = 20443
Number of patients with CeV and CaV events	479
Number of patients with no CeV and CaV events	19964

Population analysed: All of observed 20,443 patients were included as intention to treat set

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent through the end of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan	1,058 of 20,443 (5.2%)	0 of 20,443 (0%)	Not reported

Limitations and caveats (from the sponsor): This study is prospective observational study with no limitation of other antihypertensive treatment in compliance with Japanese Pharmaceutical Affairs Law (JPAL) and Good Post-marketing Study Practice (GPSP).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, 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

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim.

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 1 inclusion and 3 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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 20 Mar 2012). 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?

Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events (time frame: 3 years after initiation of treatment). 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 NCT00659581.

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 25 Aug 2016.