Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

An observational study of Hypertension and Obesity, run by Boehringer Ingelheim at 2,389 sites in Germany.

Completed

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

Trial summary

This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Obesity
How many people: 5,827 participants
Where: 2,389 sitesGermany
Study dates: Jan 2007to Nov 2007
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: hypertensive patients

Who may be able to join

patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Who cannot join

according to SPC

Trial locations and contacts

2,389 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Boehringer Ingelheim Investigational Site 1
Aachen
Boehringer Ingelheim Investigational Site 2
Aachen
Boehringer Ingelheim Investigational Site 3
Aachen
Boehringer Ingelheim Investigational Site 4
Aachen
Boehringer Ingelheim Investigational Site 5
Aachen
Boehringer Ingelheim Investigational Site 6
Aachen
Boehringer Ingelheim Investigational Site 7
Aachen
Boehringer Ingelheim Investigational Site 8
Aachen
Boehringer Ingelheim Investigational Site
Aalen
Boehringer Ingelheim Investigational Site
Aarbergen
Boehringer Ingelheim Investigational Site
Abstatt
Boehringer Ingelheim Investigational Site
Achern
Boehringer Ingelheim Investigational Site 1
Adendorf
Boehringer Ingelheim Investigational Site 2
Adendorf
Boehringer Ingelheim Investigational Site 3
Adendorf
Boehringer Ingelheim Investigational Site
Aham
Boehringer Ingelheim Investigational Site 1
Ahaus
Boehringer Ingelheim Investigational Site 2
Ahaus
Boehringer Ingelheim Investigational Site
Ahlen
Boehringer Ingelheim Investigational Site
Ahorn
Boehringer Ingelheim Investigational Site
Ahorntal
Boehringer Ingelheim Investigational Site
Ahrensbök
Boehringer Ingelheim Investigational Site
Ahrensburg
Boehringer Ingelheim Investigational Site
Ahrensfelde
Boehringer Ingelheim Investigational Site
Aichach
Boehringer Ingelheim Investigational Site
Aichtal
Boehringer Ingelheim Investigational Site
Ainring
Boehringer Ingelheim Investigational Site
Albbruck
Boehringer Ingelheim Investigational Site 1
Albstadt
Boehringer Ingelheim Investigational Site 2
Albstadt
Boehringer Ingelheim Investigational Site 3
Albstadt
Boehringer Ingelheim Investigational Site 4
Albstadt
Boehringer Ingelheim Investigational Site
Aldenhoven
Boehringer Ingelheim Investigational Site
Alfeld
Boehringer Ingelheim Investigational Site
Algermissen
Boehringer Ingelheim Investigational Site
Allendorf
Boehringer Ingelheim Investigational Site
Allmendingen
Boehringer Ingelheim Investigational Site 1
Alpen
Boehringer Ingelheim Investigational Site 2
Alpen
Boehringer Ingelheim Investigational Site
Alsdorf
Boehringer Ingelheim Investigational Site
Altena
Boehringer Ingelheim Investigational Site 1
Altenburg
Boehringer Ingelheim Investigational Site 2
Altenburg
Boehringer Ingelheim Investigational Site 1
Altenholz
Boehringer Ingelheim Investigational Site 2
Altenholz
Boehringer Ingelheim Investigational Site 3
Altenholz
Boehringer Ingelheim Investigational Site 1
Altenstadt
Boehringer Ingelheim Investigational Site 2
Altenstadt
Boehringer Ingelheim Investigational Site
Altensteig
Boehringer Ingelheim Investigational Site
Altlußheim
Boehringer Ingelheim Investigational Site
Altmittweida
Boehringer Ingelheim Investigational Site
Altötting
Boehringer Ingelheim Investigational Site
Altrip
Boehringer Ingelheim Investigational Site
Alzenau in Unterfranken
Boehringer Ingelheim Investigational Site
Amberg
Boehringer Ingelheim Investigational Site
Ammerbuch
Boehringer Ingelheim Investigational Site
Anklam
Boehringer Ingelheim Investigational Site
Ansbach
Boehringer Ingelheim Investigational Site
Apelern
Boehringer Ingelheim Investigational Site 1
Apolda
Boehringer Ingelheim Investigational Site 2
Apolda
Boehringer Ingelheim Investigational Site
Appenweier
Boehringer Ingelheim Investigational Site
Arenshausen
Boehringer Ingelheim Investigational Site
Artern
Boehringer Ingelheim Investigational Site 1
Arzberg
Boehringer Ingelheim Investigational Site 2
Arzberg
Boehringer Ingelheim Investigational Site
Aschaffenburg
Boehringer Ingelheim Investigational Site 1
Aschersleben
Boehringer Ingelheim Investigational Site 2
Aschersleben
Boehringer Ingelheim Investigational Site
Aspach
Boehringer Ingelheim Investigational Site 1
Aßlar
Boehringer Ingelheim Investigational Site 2
Aßlar
Boehringer Ingelheim Investigational Site
Attendorn
Boehringer Ingelheim Investigational Site
Attenkirchen
Boehringer Ingelheim Investigational Site
Auerbach
Boehringer Ingelheim Investigational Site 1
Augsburg
Boehringer Ingelheim Investigational Site 2
Augsburg
Boehringer Ingelheim Investigational Site 3
Augsburg
Boehringer Ingelheim Investigational Site 4
Augsburg
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Augsburg
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Auw
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Baar-Ebenhausen
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Babenhausen
Boehringer Ingelheim Investigational Site 1
Backnang
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Baienfurt
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Bamberg
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Barchfeld
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Barchfeld
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Barmstedt
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Bärnau
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Barsinghausen
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Barßel
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Barth
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Baunatal
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Bautzen
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Bautzen
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Bautzen
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Bayreuth
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Bechtheim
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Beckum
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Beeskow
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Belm
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Bensheim
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Berching
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Berchtesgaden
Boehringer Ingelheim Investigational Site 1
Bergfelde
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Bergfelde
Boehringer Ingelheim Investigational Site 1
Bergheim
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Bergheim
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Bergisch Gladbach
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Bergisch Gladbach
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Bergisch Gladbach
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Bergisch Gladbach
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Bergkamen
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Bergkamen
Boehringer Ingelheim Investigational Site 1
Bergrheinfeld
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Bergrheinfeld
Boehringer Ingelheim Investigational Site 10
Berlin
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Bernburg
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Bernburg
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Bernhardswald
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Bernsdorf
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Bernsdorf
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Besigheim
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Bestwig
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Beucha
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Bevern
Boehringer Ingelheim Investigational Site 1
Biberach
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Biedenkopf

Other trials in Germany

About this study

Official title: TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients

Read the detailed description

Study Design:

Conditions: Hypertension, Obesity
Medical subject headings: Hypertension, Obesity

What is being measured

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

Blood pressure reduction
Measured: 4 month

Secondary outcomes (1)

Change in metabolic parameters Safety

Timeline

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

Jan 2007Nov 2007

First posted4 Oct 2007 (estimated)
Study startJan 2007
Primary completionNov 2007

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
Time perspective: Prospective
Enrolment: 5,827 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00539487
Sponsor's protocol ID: 502.523
Status last verified: Nov 2013
First submitted: 25 Sep 2007
Last updated: 8 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients
ClinicalTrials.gov ID: NCT00539487
Acronym / sponsor ID: 502.523
Conditions: Hypertension, Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 5,827 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Nov 2007 (actual)
First posted: 4 Oct 2007 (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.

Detailed description

Study Design:

Study design

Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: hypertensive patients

Key inclusion criteria (1 listed)

patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Key exclusion criteria (1 listed)

according to SPC

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Blood pressure reduction
Time frame: 4 month

1 secondary outcome

Change in metabolic parameters Safety

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 8 Nov 2013.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

2,389 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Obesity, run by Boehringer Ingelheim at 2,389 sites in Germany.

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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2,389 sites in Germany. 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?

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: 4 month). 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 NCT00539487.

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 8 Nov 2013.