HypertensionNCT02176850
Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy 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?
- Micardis®
- How many people
- 19,870 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to May 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: Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice
Who may be able to join
- Patients of both sexes with essential hypertension and a minimum age of 18 years
Who cannot join
None listed.
About this study
Official title: Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension
This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.
- Conditions
- Hypertension
- Being tested
- Micardis®
- 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
| Study group | Role | What they receive |
|---|---|---|
| Micardis® | Not described Receives: Drug: Micardis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicence of ulcera
Measured: Up to 6 months after start of study
Incidence of gastrointestinal (GI) bleedings
Measured: Up to 6 months after start of study
Secondary outcomes (3)
Incidence of adverse events (GI-complaints inclusive)
Measured: Up to 6 months after start of study
Change from baseline in office blood pressure
Measured: Up to 6 months after start of study
Response rate
full response: reduction of diastolic blood pressure (DBP) by >= 10 mmHg or final DBP <= 90 mmHg overall response: reduction of DBP by >= 7mmHg or final DBP <= 90 mmHg
Measured: Up to 6 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJan 1999
- Primary completionMay 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
- 19,870 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
- NCT02176850
- Sponsor's protocol ID
- 502.314
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02176850
- Acronym / sponsor ID
- 502.314
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,870 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- May 2000 (actual)
- First posted
- 27 Jun 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 post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micardis® | – | Drug: Micardis® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice
Key inclusion criteria (1 listed)
- Patients of both sexes with essential hypertension and a minimum age of 18 years
Key exclusion criteria (0 listed)
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 | Micardis® |
Primary outcome
Indicence of ulcera
Time frame: Up to 6 months after start of study
Incidence of gastrointestinal (GI) bleedings
Time frame: Up to 6 months after start of study
3 secondary outcomes
Incidence of adverse events (GI-complaints inclusive)
Time frame: Up to 6 months after start of study
Change from baseline in office blood pressure
Time frame: Up to 6 months after start of study
Response rate
Time frame: Up to 6 months after start of study
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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 0 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 8 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?
Indicence of ulcera (time frame: Up to 6 months after start of study). 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 8 Jul 2014.