Hypertension Clinical Trial
Official title:
Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
NCT number | NCT00904371 |
Other study ID # | 502.585 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | May 18, 2009 |
Last updated | August 16, 2012 |
Start date | December 2009 |
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 cardiovascular risk.
Status | Completed |
Enrollment | 211 |
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 an additional cardiovascular risk factor 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 - pregnancy and lactation - diseases involving biliary obstruction - severe liver impairment |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovenia | Boehringer Ingelheim Investigational Site 2 | Brezice | |
Slovenia | Boehringer Ingelheim Investigational Site 24 | Brezice | |
Slovenia | Boehringer Ingelheim Investigational Site 1 | Celje | |
Slovenia | Boehringer Ingelheim Investigational Site 12 | Celje | |
Slovenia | Boehringer Ingelheim Investigational Site 16 | Celje | |
Slovenia | Boehringer Ingelheim Investigational Site 17 | Celje | |
Slovenia | Boehringer Ingelheim Investigational Site 33 | Celje | |
Slovenia | Boehringer Ingelheim Investigational Site 18 | Golnik | |
Slovenia | Boehringer Ingelheim Investigational Site 23 | Golnik | |
Slovenia | Boehringer Ingelheim Investigational Site 29 | Golnik | |
Slovenia | Boehringer Ingelheim Investigational Site 32 | Golnik | |
Slovenia | Boehringer Ingelheim Investigational Site 15 | Jesenice | |
Slovenia | Boehringer Ingelheim Investigational Site 4 | Kranj | |
Slovenia | Boehringer Ingelheim Investigational Site 28 | Litija | |
Slovenia | Boehringer Ingelheim Investigational Site 26 | Ljubljana | |
Slovenia | Boehringer Ingelheim Investigational Site 3 | Ljubljana | |
Slovenia | Boehringer Ingelheim Investigational Site 35 | Ljubljana | |
Slovenia | Boehringer Ingelheim Investigational Site 6 | Ljubljana | |
Slovenia | Boehringer Ingelheim Investigational Site 14 | Maribor | |
Slovenia | Boehringer Ingelheim Investigational Site 22 | Maribor | |
Slovenia | Boehringer Ingelheim Investigational Site 20 | Murska Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 27 | Murska Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 31 | Murska Sobota | |
Slovenia | Boehringer Ingelheim Investigational Site 11 | Novo mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 19 | Novo mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 21 | Novo mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 9 | Novo mesto | |
Slovenia | Boehringer Ingelheim Investigational Site 25 | Sempeter | |
Slovenia | Boehringer Ingelheim Investigational Site 30 | Sempeter | |
Slovenia | Boehringer Ingelheim Investigational Site 34 | Sezana | |
Slovenia | Boehringer Ingelheim Investigational Site 10 | Slovenj Gradec | |
Slovenia | Boehringer Ingelheim Investigational Site 36 | Slovenj Gradec | |
Slovenia | Boehringer Ingelheim Investigational Site 13 | Topolsica | |
Slovenia | Boehringer Ingelheim Investigational Site 5 | Trbovlje | |
Slovenia | Boehringer Ingelheim Investigational Site 8 | Trbovlje | |
Slovenia | Boehringer Ingelheim Investigational Site 7 | Velenje |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Systolic Blood Pressure (SBP) | Baseline to 3rd visit (4-10 months) | No | |
Primary | Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline to 3rd visit (4-10 months) | No | |
Primary | 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. | Baseline to 3rd visit (4-10 months) | No |
Primary | 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). | Baseline to 3rd visit (4-10 months) | No |
Primary | 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). | Baseline to 3rd visit (4-10 months) | No |
Primary | 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. | Baseline to 3rd visit (4-10 months) | No |
Secondary | 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 | 3rd visit (4-10 months) | No |
Secondary | 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. | 3rd visit (4-10 months) | No |
Secondary | Change in Heart Rate From Baseline to Study End | Baseline to 3rd visit (4-10 months) | No | |
Secondary | Number of Patients With Adverse Events (AE) | 4-10 months | No | |
Secondary | Number of Participants Not Completing Study | Number of participants discontinuing study early for given reason | 3rd visit (4-10 months) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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