HypertensionNCT02248129
Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan and hydrochlorothiazide
- How many people
- 4,255 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 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: Hypertensive patients treated in general practice
Who may be able to join
- Hypertensive patients already treated for at least 1 month with Telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason
Who cannot join
- NA
About this study
Official title: Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated in General Practice With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide, the Level of Blood Pressure Control and the Modalities of Arterial Hypertension Management
Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark)
- Conditions
- Hypertension
- Being tested
- Telmisartan and hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan and hydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Not described Receives: Drug: Telmisartan and hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with low blood pressure
lower than 140/90 mmHg in the general population of hypertensive patients, hypertensive diabetics and hypertensive with renal insufficiency
Measured: up to 4 weeks
Secondary outcomes (1)
Number of patients with adverse events
Measured: up to 4 weeks
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 startApr 2006
- Primary completionDec 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
- 4,255 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
- NCT02248129
- Sponsor's protocol ID
- 502.508
- Status last verified
- Sep 2014
- First submitted
- 22 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
- Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated in General Practice With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide, the Level of Blood Pressure Control and the Modalities of Arterial Hypertension Management
- ClinicalTrials.gov ID
- NCT02248129
- Acronym / sponsor ID
- 502.508
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,255 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2006 (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.
Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Drug: Telmisartan and hydrochlorothiazide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypertensive patients treated in general practice
Key inclusion criteria (1 listed)
- Hypertensive patients already treated for at least 1 month with Telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason
Key exclusion criteria (1 listed)
- NA
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 and hydrochlorothiazide | Drug | Hypertensive patients |
Primary outcome
Percentage of patients with low blood pressure
Time frame: up to 4 weeks
lower than 140/90 mmHg in the general population of hypertensive patients, hypertensive diabetics and hypertensive with renal insufficiency
1 secondary outcome
Number of patients with adverse events
Time frame: up to 4 weeks
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?
Percentage of patients with low blood pressure (time frame: up to 4 weeks). 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.