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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 295
- Locations
- 49
- Primary Endpoint
- Change in Systolic Blood Pressure From Baseline to Study End
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 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
- 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
Arms & Interventions
Patients with arterial hypertension
Intervention: Telmisartan or Telmisartan and Hydrochlorthiazide (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)(Visit 3 (6 months from baseline))
- Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)(6 Months)
- Change in Heart Rate From Baseline to Study End(From baseline to visit 3 (6 months))
- Number of Participants Not Completing Study(3rd visit (6 months))
- Number of Patients With Adverse Events (AE)(6 months)