HypertensionNCT02200094
Micardis®. Observational Study in Patients With Essential Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of Telmisartan, once daily and High dose of Telmisartan, once daily
- How many people
- 4,532 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Oct 2000
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients over 18 years of age suffering essential hypertension, treated by general practitioners and/or specialists
Who may be able to join
- Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician
Who cannot join
- Hypersensitivity to the active component or to any of the excipients
- Pregnancy and lactation
- Biliary obstructive disorders
- Severe hepatic impairment
- Severe renal impairment
About this study
Official title: Micardis®. Observational Study
This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.
- Conditions
- Hypertension
- Being tested
- Low dose of Telmisartan, once daily, High dose of Telmisartan, once daily
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of Telmisartan, once dailyDrug
Also called Micardis®
High dose of Telmisartan, once dailyDrug
Also called Micardis®
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with essential hypertension | Not described Receives: Drug: Low dose of Telmisartan, once daily; Drug: High dose of Telmisartan, once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic and diastolic blood pressure
Measured: Baseline, 4 weeks and 3 months after start of treatment
Percentage of patients with dose titration to 80 mg
Measured: 4 weeks and 3 months after start of treatment
Number of patients with adverse events
Measured: Up to 3 months after start of treatment
Global evaluation of treatment compliance by investigator, a 6-point rating scale
Measured: 4 weeks and 3 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startDec 1999
- Primary completionOct 2000
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
- 4,532 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
- NCT02200094
- Sponsor's protocol ID
- 502.361
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micardis®. Observational Study
- ClinicalTrials.gov ID
- NCT02200094
- Acronym / sponsor ID
- 502.361
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,532 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Oct 2000 (actual)
- First posted
- 25 Jul 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.
This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients with essential hypertension | – | Drug: Low dose of Telmisartan, once daily, Drug: High dose of Telmisartan, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients over 18 years of age suffering essential hypertension, treated by general practitioners and/or specialists
Key inclusion criteria (1 listed)
- Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician
Key exclusion criteria (5 listed)
- Hypersensitivity to the active component or to any of the excipients
- Pregnancy and lactation
- Biliary obstructive disorders
- Severe hepatic impairment
- Severe renal impairment
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 |
|---|---|---|
| Low dose of Telmisartan, once dailyAlso: Micardis® | Drug | Outpatients with essential hypertension |
| High dose of Telmisartan, once dailyAlso: Micardis® | Drug | Outpatients with essential hypertension |
Primary outcome
Changes in systolic and diastolic blood pressure
Time frame: Baseline, 4 weeks and 3 months after start of treatment
Percentage of patients with dose titration to 80 mg
Time frame: 4 weeks and 3 months after start of treatment
Number of patients with adverse events
Time frame: Up to 3 months after start of treatment
Global evaluation of treatment compliance by investigator, a 6-point rating scale
Time frame: 4 weeks and 3 months after start of treatment
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 25 Jul 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 5 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 Jul 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?
Changes in systolic and diastolic blood pressure (time frame: Baseline, 4 weeks and 3 months after start of treatment). 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 25 Jul 2014.