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AzTrials

HypertensionNCT00886288

TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium

An observational study of Hypertension, run by Boehringer Ingelheim at 936 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension
How many people
2,874 participants
Where
936 sitesBelgium
Study dates
Sep 2006to Apr 2007
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: hypertensive patients

Who may be able to join

  • Age above or equal to 18, no upper limit Patient has been treated and followed up for more than 6 months by the same general practitioner (GP) Hypertension treated for at least 3 months and not under control at the time of inclusion in the study [systolic blood pressure (SBP) above or equal to 140 mmHg and diastolic blood pressure (DBP) above or equal to 90 mmHg, or SBP above or equal to 130 mmHg and DBP above or equal to 80 mmHg if patient has chronic renal insufficiency or diabetes] Results available from at least two tests of albuminuria Antihypertensive treatment remained unchanged during the month prior data collection Decision by the GP to introduce telmisartan (either in combination with hydrochlorthiazide [HCTZ] or not) in the antihypertensive treatment (normal prescription) Written informed consent of the patient to collect his/her data

Who cannot join

  • Blood pressure under control [SBP below 140 mmHg and DBP below 90 mmHg or SBP below 130 mmHg and DBP below 80 mmHg if patient has chronic renal insufficiency or diabetes] The patient refuse to allow his/her data to be collected Women of childbearing potential not using an effective contraception method, as well as women who are breastfeeding Patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (GFR) below 15 ml/min/1.73 m² Current or prior use of telmisartan within the last 12 months Change in the antihypertensive treatment during the month prior to collection of the data

Trial locations and contacts

936 sites in 1 country.

300 sites in 1 country

Belgium300 sites

  • Boehringer Ingelheim Investigational Site 1

    Aalst

  • Boehringer Ingelheim Investigational Site 2

    Aalst

  • Boehringer Ingelheim Investigational Site 3

    Aalst

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    Aalst

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    Aalter

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    Aalter

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    Aarschot

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    Affligem-Hekeigem

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Other trials in Belgium

About this study

Official title: A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria.

This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.

Conditions
Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00886288
Study groupRoleWhat they receive
TelmisartanNot described
Telmisartan + hydrochlorothiazideNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Controlled Blood Pressure

    Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:

    • no chronic renal insufficiency or macroalbuminuria-dipsticks negative,
    • albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine
    • no diabetes or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:
    • chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine
    • diabetes (type 1 or 2)

    Measured: approximately 12 weeks (10 to 14 weeks) after baseline

Secondary outcomes (5)

  1. Mean Difference in Systolic Blood Pressure

    The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg

    Measured: baseline and approximately 12 weeks

  2. Mean Difference in Diastolic Blood Pressure

    The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg

    Measured: baseline and approximately 12 weeks

  3. Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)

    The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg

    Measured: approximately 12 weeks (10 to 14 weeks) after baseline

  4. Percentage of Patients Presenting an Adverse Event (AE)

    Percentage of patients with any adverse events during the study period, related or not to investigational drug

    Measured: baseline to the end of study period

  5. Percentage of Patients With Positive to Negative Shift in Albuminuria

    Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks

    Measured: Approximately 12 weeks (10 to 14 weeks) after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2009 (estimated)
  2. Study startSep 2006
  3. Primary completionApr 2007

Resources

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 only
Time perspective
Prospective
Enrolment
2,874 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00886288
Sponsor's protocol ID
502.521
Status last verified
Jun 2014
First submitted
21 Apr 2009
Last updated
17 Jun 2014

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 936 sites in Belgium.

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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 936 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 18 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Controlled Blood Pressure (time frame: approximately 12 weeks (10 to 14 weeks) after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00886288.

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 17 Jun 2014.

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