HypertensionNCT01108809
Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients
An observational study of Hypertension, run by Boehringer Ingelheim at 49 sites in Romania.
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 risk scores. The study will also 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
- What is being tested?
- Telmisartan or Telmisartan and Hydrochlorthiazide
- How many people
- 295 participants
- Where
- 49 sitesRomania
- Study dates
- Apr 2010to 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
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 one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease
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, as prescribed in the SPC
- pregnancy and lactation
- diseases involving biliary obstruction
- severe liver impairment
- severe hypertension
- malignant hypertension
- secondary hypertension
- patients age under 18 years
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Romania49 sites
Boehringer Ingelheim Investigational Site 1
Arad
Boehringer Ingelheim Investigational Site 5
Bacau
Boehringer Ingelheim Investigational Site 6
Baia Mare
Boehringer Ingelheim Investigational Site 8
Brăila
Boehringer Ingelheim Investigational Site 9
Brasov
Boehringer Ingelheim Investigational Site 10
Bucharest
Boehringer Ingelheim Investigational Site 11
Bucharest
Boehringer Ingelheim Investigational Site 12
Bucharest
Boehringer Ingelheim Investigational Site 13
Bucharest
Boehringer Ingelheim Investigational Site 14
Bucharest
Boehringer Ingelheim Investigational Site 15
Bucharest
Boehringer Ingelheim Investigational Site 16
Bucharest
Boehringer Ingelheim Investigational Site 17
Bucharest
Boehringer Ingelheim Investigational Site 18
Bucharest
Boehringer Ingelheim Investigational Site 19
Bucharest
Boehringer Ingelheim Investigational Site 20
Bucharest
Boehringer Ingelheim Investigational Site 21
Bucharest
Boehringer Ingelheim Investigational Site 22
Bucharest
Boehringer Ingelheim Investigational Site 23
Buzău
Boehringer Ingelheim Investigational Site 24
Calarasi
Boehringer Ingelheim Investigational Site 4
Campulung Muscel
Boehringer Ingelheim Investigational Site 42
Carei
Boehringer Ingelheim Investigational Site 26
Cluj-Napoca
Boehringer Ingelheim Investigational Site 27
Cluj-Napoca
Boehringer Ingelheim Investigational Site 28
Cluj-Napoca
Boehringer Ingelheim Investigational Site 29
Constanța
Boehringer Ingelheim Investigational Site 31
Craiova
Boehringer Ingelheim Investigational Site 2
Curtea de Argeş
Boehringer Ingelheim Investigational Site 38
Drobeta-Turnu Severin
Boehringer Ingelheim Investigational Site 32
Galati
Boehringer Ingelheim Investigational Site 34
Iași
Boehringer Ingelheim Investigational Site 35
Iași
Boehringer Ingelheim Investigational Site 36
Iași
Boehringer Ingelheim Investigational Site 37
Iași
Boehringer Ingelheim Investigational Site 7
Oradea
Boehringer Ingelheim Investigational Site 3
Piteşti
Boehringer Ingelheim Investigational Site 40
Ploieşti
Boehringer Ingelheim Investigational Site 41
Ploieşti
Boehringer Ingelheim Investigational Site 49
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 25
Reşiţa
Boehringer Ingelheim Investigational Site 33
Slobozia
Boehringer Ingelheim Investigational Site 43
Suceava
Boehringer Ingelheim Investigational Site 30
Targoviste
Boehringer Ingelheim Investigational Site 39
Târgu Mureş
Boehringer Ingelheim Investigational Site 44
Timișoara
Boehringer Ingelheim Investigational Site 45
Timișoara
Boehringer Ingelheim Investigational Site 46
Timișoara
Boehringer Ingelheim Investigational Site 47
Timișoara
Boehringer Ingelheim Investigational Site 48
Tulcea
About this study
Official title: Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.
- Conditions
- Hypertension
- Being tested
- Telmisartan or Telmisartan and Hydrochlorthiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan or Telmisartan and HydrochlorthiazideDrug
Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg
| Study group | Role | What they receive |
|---|---|---|
| Patients with arterial hypertension | Not described Receives: Drug: Telmisartan or Telmisartan and Hydrochlorthiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure From Baseline to Study End
Measured: From baseline to visit 3 (6 months)
Change in Diastolic Blood Pressure From Baseline to Study End
Measured: From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Measured: From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Measured: From baseline to visit 3 (6 months)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Measured: From baseline to visit 3 (6 months)
Secondary outcomes (5)
Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (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: Visit 3 (6 months from baseline)
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Measured: 6 Months
Change in Heart Rate From Baseline to Study End
Measured: From baseline to visit 3 (6 months)
Number of Participants Not Completing Study
Number of participants discontinuing study early for given reason
Measured: 3rd visit (6 months)
Number of Patients With Adverse Events (AE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- 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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108809
- Sponsor's protocol ID
- 502.592
- Status last verified
- Feb 2014
- First submitted
- 19 Apr 2010
- Last updated
- 28 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01108809
- Acronym / sponsor ID
- 502.592
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Posted 24 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with arterial hypertension | – | Drug: Telmisartan or Telmisartan and Hydrochlorthiazide |
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
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 one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease
Key exclusion criteria (8 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, as prescribed in the SPC
- pregnancy and lactation
- diseases involving biliary obstruction
- severe liver impairment
- severe hypertension
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 or Telmisartan and HydrochlorthiazideTelmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg | Drug | Patients with arterial hypertension |
Primary outcome
Change in Systolic Blood Pressure From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Change in Diastolic Blood Pressure From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
Time frame: From baseline to visit 3 (6 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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
5 secondary outcomes
Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)
Time frame: Visit 3 (6 months from baseline)
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Time frame: 6 Months
Change in Heart Rate From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Number of Participants Not Completing Study
Time frame: 3rd visit (6 months)
Number of Patients With Adverse Events (AE)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
49 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, run by Boehringer Ingelheim at 49 sites in Romania.
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 8 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Romania. 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 24 Sep 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 in Systolic Blood Pressure From Baseline to Study End (time frame: From baseline to visit 3 (6 months)). The study lists 5 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 28 Mar 2014.