Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 211
- Locations
- 36
- Primary Endpoint
- Change From Baseline in Systolic Blood Pressure (SBP)
Study Overview
Brief 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 cardiovascular risk.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)(3rd visit (4-10 months))
- Change in Heart Rate From Baseline to Study End(Baseline to 3rd visit (4-10 months))
- Number of Patients With Adverse Events (AE)(4-10 months)
- Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC(3rd visit (4-10 months))
- Number of Participants Not Completing Study(3rd visit (4-10 months))