HypertensionNCT02187705
Micardis® in Patients With Essential Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals 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 tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 1,688 participants
- Where
- No sites listed yet
- Study dates
- May 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
Who may be able to join
- Patients with essential hypertension
- Minimum age of 18 years
Who cannot join
None listed.
About this study
Official title: Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals
The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals
- Conditions
- Hypertension
- Being tested
- Telmisartan tablets
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan tabletsDrug
Also called Micardis®
All patients were treated with different doses of telmisartan for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with normotension at baseline | Not described Receives: Drug: Telmisartan tablets | |
| Patients with essential hypertension at baseline | Not described Receives: Drug: Telmisartan tablets | |
| Patients with isolated hypertension at baseline | Not described Receives: Drug: Telmisartan tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in blood pressure
Evaluation was performed separately for three patient groups depending on their hypertension status at baseline (normotension, essential hypertension and isolated hypertension)
Measured: Up to 14 days
Number of patients with adverse events
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 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
- 1,688 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
- NCT02187705
- Sponsor's protocol ID
- 502.322
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals
- ClinicalTrials.gov ID
- NCT02187705
- Acronym / sponsor ID
- 502.322
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,688 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1999
- Primary completion
- May 2000 (actual)
- First posted
- 11 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.
The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with normotension at baseline | – | Drug: Telmisartan tablets |
| Patients with essential hypertension at baseline | – | Drug: Telmisartan tablets |
| Patients with isolated hypertension at baseline | – | Drug: Telmisartan tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with essential hypertension
- 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 |
|---|---|---|
| Telmisartan tabletsAlso: Micardis®All patients were treated with different doses of telmisartan for 14 days | Drug | Patients with essential hypertension at baseline, Patients with isolated hypertension at baseline, Patients with normotension at baseline |
Primary outcome
Changes from baseline in blood pressure
Time frame: Up to 14 days
Evaluation was performed separately for three patient groups depending on their hypertension status at baseline (normotension, essential hypertension and isolated hypertension)
Number of patients with adverse events
Time frame: Up to 14 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 11 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 2 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 11 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 from baseline in blood pressure (time frame: Up to 14 days). 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 11 Jul 2014.