HypertensionNCT02262637
Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Micardis® and MicardisPlus®
- How many people
- 4,814 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with hypertension recruited at Cardiologists, Nephrologists, Diabetologists
Who may be able to join
- Age >= 18 years
Who cannot join
- Age < 18 years
About this study
Official title: Micardis® / MicardisPlus® PROTEKT (Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases)
Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists
- Conditions
- Hypertension
- Being tested
- Micardis®, MicardisPlus®
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micardis®Drug
MicardisPlus®Drug
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients - Cardiologists | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® | |
| Hypertensive patients - Nephrologists | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® | |
| Hypertensive patients - Diabetologists | Not described Receives: Drug: Micardis®; Drug: MicardisPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure (SBP)
Measured: baseline, up to 6 months
Change in diastolic blood pressure (DBP)
Measured: baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2003
- Primary completionMar 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
- 4,814 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
- NCT02262637
- Sponsor's protocol ID
- 502.441
- Other IDs
- 502.442, 502.443
- Status last verified
- Oct 2014
- First submitted
- 10 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micardis® / MicardisPlus® PROTEKT (Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases)
- ClinicalTrials.gov ID
- NCT02262637
- Acronym / sponsor ID
- 502.441
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,814 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Mar 2006 (actual)
- First posted
- 13 Oct 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.
Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients - Cardiologists | – | Drug: Micardis®, Drug: MicardisPlus® |
| Hypertensive patients - Nephrologists | – | Drug: Micardis®, Drug: MicardisPlus® |
| Hypertensive patients - Diabetologists | – | Drug: Micardis®, Drug: MicardisPlus® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with hypertension recruited at Cardiologists, Nephrologists, Diabetologists
Key inclusion criteria (1 listed)
- Age >= 18 years
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| Micardis® | Drug | Hypertensive patients - Cardiologists, Hypertensive patients - Diabetologists, Hypertensive patients - Nephrologists |
| MicardisPlus® | Drug | Hypertensive patients - Cardiologists, Hypertensive patients - Diabetologists, Hypertensive patients - Nephrologists |
Primary outcome
Change in systolic blood pressure (SBP)
Time frame: baseline, up to 6 months
Change in diastolic blood pressure (DBP)
Time frame: baseline, up to 6 months
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 13 Oct 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 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 13 Oct 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?
Change in systolic blood pressure (SBP) (time frame: baseline, up to 6 months). The study lists 2 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 13 Oct 2014.