PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg

Study Overview
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Brief Summary
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PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients will have essential hypertension. In addition, the patients will have at least one other contributing risk factor for cardiovascular events. The study aims to evaluate the safety, efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in patients with essential hypertension

Official Title
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To Evaluate the Safety, Efficacy, and Protection of Micardis 80 mg/Micardis Plus 80/12.5 mg From Cardiovascular Risks in a 24 Weeks Observational Study in Patients With Essential Hypertension Who Have at Least One Other Known Cardio-vascular Risk Factor

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female Aged 20 to 80 years old. adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled Sitting blood pressure: systolic BP > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg) At least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as > 55 years (Males), > 65 years (Females), smoking, overweight or obese patients or a combination of above risk factors Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication Exclusion criteria: Patients with contraindications to Telmisartan use (as per the Micardis® Tablets package insert). Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® . Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications. Patients participating in any other clinical trial. Patients already on Micardis® alone or combination Pregnant females, or females breast feeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Essential hypertensive men and women<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. | Baseline and Week 24 | 
| Change in Systolic Blood Pressure From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham Score at Week 24 | The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Week 24 | 
| Change in the Framingham Score From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk). | Baseline and Week 24 | 
| International Renal Interest Society (IRIS) II Score at Week 24 | The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Week 24 | 
| Change in the IRIS II Score From Baseline at Week 24 | The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk). | Baseline and Week 24 | 
| Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results) | The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24 | Baseline and Week 24 |