Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

Study Overview
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Brief Summary
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This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions. The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control. In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.

Official Title
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Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients) Patients with hypertension under treatment with one or more antihypertensive drug Exclusion criteria: Patients are excluded according to the summary of product characteristics (SmPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at cardiovascular risk<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 
| Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 
| Changes in Laboratory Parameters:High Density Lipoprotein (HDL) | Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 
| Changes in Laboratory Parameters: Triglycerides | Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 
| Changes in Laboratory Parameters: Blood Glucose | Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool | 24 weeks (Visit 1 to Visit 3) | 
| Assessment of Metabolic Effect | Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative' | 24 weeks (Visit 1 to Visit 3) |