Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

Study Overview
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Brief Summary
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This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market: Unexpected adverse drug reactions (especially, serious adverse events (SAEs)) Frequency of incidence and its change in adverse events (AEs) Factors on the safety profile of the study drug Factors on the efficacy profile of the study drug

Official Title
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PMS Study of MicardisPlus Tablet

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with essential hypertension Exclusion Criteria: patients who took Micardis Plus before participating in this PMS study

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unexpected Adverse Events | Occurrence status of unexpected adverse events | Up to 6 years | 
| Frequency of Adverse Events |  | Up to 6 years | 
| Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 | Effect on decrease in systolic blood pressure | Baseline and End of Study | 
| Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 | Effect on decrease in diastolic blood pressure | Baseline and End of Study | 
| Effective Rate | Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed) | Baseline and End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender Factors Affecting the Safety Profile | Occurrence status of adverse events by Gender category of patients | Up to 6 years | 
| Age Factors Affecting the Safety Profile | Occurrence status of adverse events by Age category of patients | Up to 6 years | 
| Proportion of Geriatric Population Factor Affecting the Safety Profile | Occurrence status of adverse events by Proportion of geriatric population of patients | Up to 6 years | 
| Treatment Type Factors Affecting the Safety Profile | Occurrence status of adverse events by Treatment type of patients | Up to 6 years | 
| Medical History Factors Affecting the Safety Profile | Occurrence status of adverse events by medical history of patients | Up to 6 years | 
| Concomitant Disease Factors Affecting the Safety Profile | Occurrence status of adverse events by Concomitant disease of patients | Up to 6 years | 
| Medical History Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Baseline and End of Study | 
| Previous Medication Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Baseline and End of Study | 
| Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients Stage 1 (SBP 140 159 mmHg or DBP 90 99 mmHg) Stage 2 (SBP 160 179 mmHg or DBP 100 109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg) | Baseline and End of Study | 
| Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients 40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists | Baseline and End of Study |