Hypertension Clinical Trial
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
| NCT number | NCT01108809 |
| Other study ID # | 502.592 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | April 19, 2010 |
| Last updated | February 28, 2014 |
| Start date | April 2010 |
| Verified date | February 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Romania: Ministry of Public Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 295 |
| Est. completion date | |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - 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 Exclusion criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Romania | Boehringer Ingelheim Investigational Site 1 | Arad | |
| Romania | Boehringer Ingelheim Investigational Site 5 | Bacau | |
| Romania | Boehringer Ingelheim Investigational Site 6 | Baia Mare | |
| Romania | Boehringer Ingelheim Investigational Site 8 | Braila | |
| Romania | Boehringer Ingelheim Investigational Site 9 | Brasov | |
| Romania | Boehringer Ingelheim Investigational Site 10 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 11 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 12 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 13 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 14 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 15 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 16 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 17 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 18 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 19 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 20 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 21 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 22 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 23 | Buzau | |
| Romania | Boehringer Ingelheim Investigational Site 24 | Calarasi | |
| Romania | Boehringer Ingelheim Investigational Site 4 | Campulung | |
| Romania | Boehringer Ingelheim Investigational Site 42 | Carei | |
| Romania | Boehringer Ingelheim Investigational Site 26 | Cluj-Napoca | |
| Romania | Boehringer Ingelheim Investigational Site 27 | Cluj-Napoca | |
| Romania | Boehringer Ingelheim Investigational Site 28 | Cluj-Napoca | |
| Romania | Boehringer Ingelheim Investigational Site 29 | Constanta | |
| Romania | Boehringer Ingelheim Investigational Site 31 | Craiova | |
| Romania | Boehringer Ingelheim Investigational Site 2 | Curtea de Arges | |
| Romania | Boehringer Ingelheim Investigational Site 38 | Drobeta-Turnu Severin | |
| Romania | Boehringer Ingelheim Investigational Site 32 | Galati | |
| Romania | Boehringer Ingelheim Investigational Site 34 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 35 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 36 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 37 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 7 | Oradea | |
| Romania | Boehringer Ingelheim Investigational Site 3 | Pitesti | |
| Romania | Boehringer Ingelheim Investigational Site 40 | Ploiesti | |
| Romania | Boehringer Ingelheim Investigational Site 41 | Ploiesti | |
| Romania | Boehringer Ingelheim Investigational Site 49 | Ramnicu-Valcea | |
| Romania | Boehringer Ingelheim Investigational Site 25 | Resita | |
| Romania | Boehringer Ingelheim Investigational Site 33 | Slobozia | |
| Romania | Boehringer Ingelheim Investigational Site 43 | Suceava | |
| Romania | Boehringer Ingelheim Investigational Site 30 | Targoviste | |
| Romania | Boehringer Ingelheim Investigational Site 39 | Targu-Mures | |
| Romania | Boehringer Ingelheim Investigational Site 44 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 45 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 46 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 47 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 48 | Tulcea |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure From Baseline to Study End | From baseline to visit 3 (6 months) | No | |
| Primary | Change in Diastolic Blood Pressure From Baseline to Study End | From baseline to visit 3 (6 months) | No | |
| Primary | 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) | From baseline to visit 3 (6 months) | No |
| Primary | 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) | From baseline to visit 3 (6 months) | No |
| Primary | 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) | From baseline to visit 3 (6 months) | No |
| Secondary | 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 | Visit 3 (6 months from baseline) | No |
| Secondary | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | 6 Months | No | |
| Secondary | Change in Heart Rate From Baseline to Study End | From baseline to visit 3 (6 months) | No | |
| Secondary | Number of Participants Not Completing Study | Number of participants discontinuing study early for given reason | 3rd visit (6 months) | No |
| Secondary | Number of Patients With Adverse Events (AE) | 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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