HypertensionNCT02245464
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years 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
- 13,066 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Nov 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: Patients with essential hypertension and without prior Micardis experience
Who may be able to join
- Male and female patients diagnosed with essential hypertension
- Patients without prior experience with Micardis tablet
Who cannot join
- Known hypersensitivity to Micardis tablet
- Pregnancy or breastfeeding
- Biliary atresia
- Severe hepatic failure patients
- Severe renal failure patients
About this study
Official title: The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with essential hypertension | Not described Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
Measured: Up to 6 years
Final assessment of efficacy on a 3-point scale
Measured: Up to 6 years
Assessment of efficacy based on subject's demographics on a two-point scale
Measured: Up to 6 years
Number of patients with adverse events
Measured: Up to 6 years
Incidence rate of adverse events
based on demographic factors
Measured: Up to 6 years
Assessment of safety on a 4-point scale
based on adverse events and changes in abnormality of clinical laboratory tests
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startNov 2000
- Primary completionNov 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
- 13,066 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
- NCT02245464
- Sponsor's protocol ID
- 502.479
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)
- ClinicalTrials.gov ID
- NCT02245464
- Acronym / sponsor ID
- 502.479
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,066 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2000
- Primary completion
- Nov 2006 (actual)
- First posted
- 19 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 objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with essential hypertension | – | Drug: Telmisartan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with essential hypertension and without prior Micardis experience
Key inclusion criteria (2 listed)
- Male and female patients diagnosed with essential hypertension
- Patients without prior experience with Micardis tablet
Key exclusion criteria (5 listed)
- Known hypersensitivity to Micardis tablet
- Pregnancy or breastfeeding
- Biliary atresia
- Severe hepatic failure patients
- Severe renal failure patients
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 |
|---|---|---|
| Telmisartan | Drug | Patients with essential hypertension |
Primary outcome
Blood pressure reduction
Time frame: Up to 6 years
Final assessment of efficacy on a 3-point scale
Time frame: Up to 6 years
Assessment of efficacy based on subject's demographics on a two-point scale
Time frame: Up to 6 years
Number of patients with adverse events
Time frame: Up to 6 years
Incidence rate of adverse events
Time frame: Up to 6 years
based on demographic factors
Assessment of safety on a 4-point scale
Time frame: Up to 6 years
based on adverse events and changes in abnormality of clinical laboratory tests
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 19 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 2 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 19 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?
Blood pressure reduction (time frame: Up to 6 years). The study lists 6 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 19 Sep 2014.