Telmisartan Tab Hypertension

Study Overview
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Brief Summary
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To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

Detailed Description
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Study Design:

Official Title
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RESPECT: Observational, Prospective, Open-label, Multi-center Study Evaluating the Antihypertensive Effect of Treatment With Telmisartan (Alone or in Fixed Combination With HCTZ) in General Practitioner and Specialist Practice in Hypertensive Patients With High and Very High Cardiovascular Risk According to the ESH/ESC Guidelines 2007 Who Are Uncontrolled Under Current Treatment.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria Exclusion criteria: Contra-indications as in the Summary of Product Characteristics

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 |
| --- | --- |
| Group1<br> | Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)<br>* Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Blood Pressure < 140/90 mm Hg | % of high risk patients with Blood Pressure < 140/90 mm Hg | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Blood Pressure < 130/80 mm Hg |  | 12 weeks | 
| Absolute Blood Pressure Decrease | systolic blood pressure | baseline and 12 weeks | 
| BP Response Rate (Drop of Systolic BP of 10mmHg or More) | BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ) | 12 weeks | 
| Treatment Patterns | Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications). | 12 weeks | 
| Change in Concomitant Antihypertensive Drugs Given at Study Entry | Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not. | baseline and 12 weeks | 
| Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg |  | 12 weeks | 
| Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 | Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients | 12 weeks |