HypertensionNCT02248896
Antihypertensive Medications and the Risk of Sepsis
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan, Other angiotensin-receptor blockers (ARBs) and Angiotensin-converting enzyme inhibitors (ACEIs)
- How many people
- 1,129,062 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2011
- 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 with a diagnosis of, or treatment for hypertension
Who may be able to join
- Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension
Who cannot join
- Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry
About this study
The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death
- Conditions
- Hypertension
- Being tested
- Telmisartan, Other angiotensin-receptor blockers (ARBs), Angiotensin-converting enzyme inhibitors (ACEIs), Other major antihypertensive medication classes
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Other angiotensin-receptor blockers (ARBs)Drug
Angiotensin-converting enzyme inhibitors (ACEIs)Drug
Other major antihypertensive medication classesDrug
e.g. beta-blockers, calcium channel blockers (CCBs), diuretics
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Hypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data Receives: Drug: Telmisartan; Drug: Other angiotensin-receptor blockers (ARBs); Drug: Angiotensin-converting enzyme inhibitors (ACEIs); Drug: Other major antihypertensive medication classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of sepsis, including severe sepsis
Severe sepsis defined as cases that develop renal failure or die within 30 days
Measured: Up to 9 years and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2011
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,129,062 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
- NCT02248896
- Sponsor's protocol ID
- 502.590
- Status last verified
- Sep 2014
- First submitted
- 24 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Medications and the Risk of Sepsis
- ClinicalTrials.gov ID
- NCT02248896
- Acronym / sponsor ID
- 502.590
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,129,062 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- First posted
- 25 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 study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Drug: Telmisartan, Drug: Other angiotensin-receptor blockers (ARBs), Drug: Angiotensin-converting enzyme inhibitors (ACEIs), Drug: Other major antihypertensive medication classesHypertensive patients or patients treated with antihypertensive drugs with linked GPRD and hospital episodes statistics database (HES) data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of, or treatment for hypertension
Key inclusion criteria (1 listed)
- Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension
Key exclusion criteria (1 listed)
- Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry
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 | Hypertensive patients |
| Other angiotensin-receptor blockers (ARBs) | Drug | Hypertensive patients |
| Angiotensin-converting enzyme inhibitors (ACEIs) | Drug | Hypertensive patients |
| Other major antihypertensive medication classese.g. beta-blockers, calcium channel blockers (CCBs), diuretics | Drug | Hypertensive patients |
Primary outcome
Occurence of sepsis, including severe sepsis
Time frame: Up to 9 years and 5 months
Severe sepsis defined as cases that develop renal failure or die within 30 days
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 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 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 25 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?
Occurence of sepsis, including severe sepsis (time frame: Up to 9 years and 5 months). 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 Sep 2014.