HypertensionNCT00904371

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

An observational study of Hypertension and Cardiovascular Diseases, run by Boehringer Ingelheim at 36 sites in Slovenia.

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

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks. Further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Cardiovascular Diseases
How many people: 211 participants
Where: 36 sitesSlovenia
Study dates: Dec 2009to Jan 2011
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients with arterial hypertension with moderate to very high cardiovascular risk

Who may be able to join

diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
at least an additional cardiovascular risk factor

Who cannot join

hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market
pregnancy and lactation
diseases involving biliary obstruction
severe liver impairment

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

Slovenia36 sites

Boehringer Ingelheim Investigational Site 24
Brežice
Boehringer Ingelheim Investigational Site 2
Brežice
Boehringer Ingelheim Investigational Site 12
Celje
Boehringer Ingelheim Investigational Site 16
Celje
Boehringer Ingelheim Investigational Site 17
Celje
Boehringer Ingelheim Investigational Site 1
Celje
Boehringer Ingelheim Investigational Site 33
Celje
Boehringer Ingelheim Investigational Site 18
Golnik
Boehringer Ingelheim Investigational Site 23
Golnik
Boehringer Ingelheim Investigational Site 29
Golnik
Boehringer Ingelheim Investigational Site 32
Golnik
Boehringer Ingelheim Investigational Site 15
Jesenice
Boehringer Ingelheim Investigational Site 4
Kranj
Boehringer Ingelheim Investigational Site 28
Litija
Boehringer Ingelheim Investigational Site 26
Ljubljana
Boehringer Ingelheim Investigational Site 35
Ljubljana
Boehringer Ingelheim Investigational Site 3
Ljubljana
Boehringer Ingelheim Investigational Site 6
Ljubljana
Boehringer Ingelheim Investigational Site 14
Maribor
Boehringer Ingelheim Investigational Site 22
Maribor
Boehringer Ingelheim Investigational Site 20
Murska Sobota
Boehringer Ingelheim Investigational Site 27
Murska Sobota
Boehringer Ingelheim Investigational Site 31
Murska Sobota
Boehringer Ingelheim Investigational Site 11
Novo Mesto
Boehringer Ingelheim Investigational Site 19
Novo Mesto
Boehringer Ingelheim Investigational Site 21
Novo Mesto
Boehringer Ingelheim Investigational Site 9
Novo Mesto
Boehringer Ingelheim Investigational Site 25
Sempeter
Boehringer Ingelheim Investigational Site 30
Sempeter
Boehringer Ingelheim Investigational Site 34
Sežana
Boehringer Ingelheim Investigational Site 10
Slovenj Gradec
Boehringer Ingelheim Investigational Site 36
Slovenj Gradec
Boehringer Ingelheim Investigational Site 13
Topolšica
Boehringer Ingelheim Investigational Site 5
Trbovlje
Boehringer Ingelheim Investigational Site 8
Trbovlje
Boehringer Ingelheim Investigational Site 7
Velenje

Other trials in Slovenia

About this study

Official title: Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Conditions: Hypertension, Cardiovascular Diseases
Medical subject headings: Hypertension, Cardiovascular Diseases

What participants receive

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

Study groups in NCT00904371
Study group	Role	What they receive
Patients with arterial hypertention		Not described

What is being measured

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

Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline to 3rd visit (4-10 months)
Change From Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline to 3rd visit (4-10 months)
Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.
Measured: Baseline to 3rd visit (4-10 months)
Change From Baseline in Framingham CVD Risk Assessment Score
10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Measured: Baseline to 3rd visit (4-10 months)
Change From Baseline in Framingham Stroke Risk Assessment Score
The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Measured: Baseline to 3rd visit (4-10 months)
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines
ESH is the European society of hypertension, and ESC is the European society of cardiology.
Measured: Baseline to 3rd visit (4-10 months)

Secondary outcomes (5)

Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC
ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients
Measured: 3rd visit (4-10 months)
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.
Measured: 3rd visit (4-10 months)
Change in Heart Rate From Baseline to Study End
Measured: Baseline to 3rd visit (4-10 months)
Number of Patients With Adverse Events (AE)
Measured: 4-10 months
Number of Participants Not Completing Study
Number of participants discontinuing study early for given reason
Measured: 3rd visit (4-10 months)

Timeline

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

Dec 2009Jan 2011

First posted19 May 2009 (estimated)
Study startDec 2009
Primary completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904371
Sponsor's protocol ID: 502.585
Status last verified: Aug 2012
First submitted: 18 May 2009
Last updated: 21 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

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

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
ClinicalTrials.gov ID: NCT00904371
Acronym / sponsor ID: 502.585
Conditions: Hypertension, Cardiovascular Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jan 2011 (actual)
First posted: 19 May 2009 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with arterial hypertention	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with arterial hypertension with moderate to very high cardiovascular risk

Key inclusion criteria (2 listed)

diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
at least an additional cardiovascular risk factor

Key exclusion criteria (4 listed)

hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market
pregnancy and lactation
diseases involving biliary obstruction
severe liver impairment

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

Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to 3rd visit (4-10 months)
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to 3rd visit (4-10 months)
Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)
Time frame: Baseline to 3rd visit (4-10 months)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.
Change From Baseline in Framingham CVD Risk Assessment Score
Time frame: Baseline to 3rd visit (4-10 months)
10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Change From Baseline in Framingham Stroke Risk Assessment Score
Time frame: Baseline to 3rd visit (4-10 months)
The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines
Time frame: Baseline to 3rd visit (4-10 months)
ESH is the European society of hypertension, and ESC is the European society of cardiology.

5 secondary outcomes

Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC
Time frame: 3rd visit (4-10 months)
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Time frame: 3rd visit (4-10 months)
Change in Heart Rate From Baseline to Study End
Time frame: Baseline to 3rd visit (4-10 months)
Number of Patients With Adverse Events (AE)
Time frame: 4-10 months
Number of Participants Not Completing Study
Time frame: 3rd visit (4-10 months)

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micardis® 80mg; MicardisPlus® 80/12.5 mg	211	202

Primary outcome: Change From Baseline in Systolic Blood Pressure (SBP)

Time frame: Baseline to 3rd visit (4-10 months). Mean (Standard Deviation). Unit: mm Hg

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n = 204
Value	-22.6 (17.1)

Population analysed: Patients with data both at baseline and on 3rd visit (4-10 months)

Primary outcome: Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame: Baseline to 3rd visit (4-10 months). Mean (Standard Deviation). Unit: mm Hg

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n = 203
Value	-10.1 (10.1)

Population analysed: Patients with data both at baseline and on 3rd visit (4-10 months)

Primary outcome: Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)

Time frame: Baseline to 3rd visit (4-10 months). Mean (Standard Deviation). Unit: units on a scale

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n = 172
Value	-3.9 (8.8)

Population analysed: Patients with data both at baseline and on 3rd visit (4-10 months)

Primary outcome: Change From Baseline in Framingham CVD Risk Assessment Score

Time frame: Baseline to 3rd visit (4-10 months). Mean (Standard Deviation). Unit: units on a scale

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n = 148
Value	-7.6 (8.6)

Population analysed: Patients with data both at baseline and on 3rd visit (4-10 months)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micardis® 80mg MicardisPlus® 80/12.5 mg	2 of 211 (0.9%)	0 of 211 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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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)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

36 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 Cardiovascular Diseases, run by Boehringer Ingelheim at 36 sites in Slovenia.

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 4 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 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Slovenia. 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 21 Aug 2012). 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?

Change From Baseline in Systolic Blood Pressure (SBP) (time frame: Baseline to 3rd visit (4-10 months)). The study lists 6 primary outcomes in all. 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 NCT00904371.

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 21 Aug 2012.