HypertensionNCT02242838
Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan
- How many people
- 6,336 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hypertension patients without telmisartan treatment are selected at medical institutions
Who may be able to join
- Patients with hypertension
Who cannot join
- Patients with the following conditions
- Patients with a history of hypersensitivity of this product
- Women in pregnancy (included the possibility of pregnancy)
- Patients with severe biliary obstructive disorders or severe hepatic insufficiency
About this study
Official title: Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period
- 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
Also called Micardis®
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | 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 adverse drug reactions
Measured: up to 1 year
Incidence of adverse drug reactions
classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
Measured: up to 1 year
Change in Mean systolic blood pressure (SBP)
Measured: up to 1 year
Change in Mean diastolic blood pressure (DBP)
Measured: up to 1 year
Secondary outcomes (2)
Overall assessment of efficacy by investigator on 4-point scale
Measured: at 3 month, after 1 year
Change in pulse rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2003
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 6,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242838
- Sponsor's protocol ID
- 502.500
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment
- ClinicalTrials.gov ID
- NCT02242838
- Acronym / sponsor ID
- 502.500
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,336 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Sep 2006 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Drug: Telmisartan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypertension patients without telmisartan treatment are selected at medical institutions
Key inclusion criteria (1 listed)
- Patients with hypertension
Key exclusion criteria (4 listed)
- Patients with the following conditions
- Patients with a history of hypersensitivity of this product
- Women in pregnancy (included the possibility of pregnancy)
- Patients with severe biliary obstructive disorders or severe hepatic insufficiency
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 |
|---|---|---|
| TelmisartanAlso: Micardis® | Drug | Hypertensive patients |
Primary outcome
Number of patients with adverse drug reactions
Time frame: up to 1 year
Incidence of adverse drug reactions
Time frame: up to 1 year
classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
Change in Mean systolic blood pressure (SBP)
Time frame: up to 1 year
Change in Mean diastolic blood pressure (DBP)
Time frame: up to 1 year
2 secondary outcomes
Overall assessment of efficacy by investigator on 4-point scale
Time frame: at 3 month, after 1 year
Change in pulse rate
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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 17 Sep 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 adverse drug reactions (time frame: up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.