A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)

Study Overview
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Brief Summary
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The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide. The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide. Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability

Official Title
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A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Telmisartan hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients male or female between 18 and 80 years of age Patients with mild to moderate essential hypertension Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment Exclusion Criteria: Pre-menopausal women who have no birth control, who are pregnant or nursing Patients with advanced hepatic impairment or advanced renal impairment Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months Patients with any type of relevant arrhythmia according to the assessment of the investigator Patients with any valvular disease with hemodynamic repercussion Patients receiving chronic administration of oral anticoagulants or digoxin Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors Patients with severe, uncontrolled hypertension or any form of secondary hypertension Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Hypertensive patients<br> | Drug: Telmisartan<br> <br> * Other names: Micardis®;Drug: Telmisartan hydrochlorothiazide<br> <br> * Other names: Micardis Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of degree of Blood Pressure (BP) control in the early morning hours |  | 8 weeks of treatment | 
| Change from baseline in mSBP and mDBP by HBPM in the early morning | BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements) | Baseline, after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in office BP control rates |  | Baseline, after 8 weeks | 
| Change from baseline in office BP response rates |  | Baseline, after 8 weeks | 
| Reduction in mSBP and mDBP by OBPM |  | Baseline, after 8 weeks | 
| Number of patients with adverse events |  | up to 8 weeks | 
| Global Assessment of tolerability by investigator on a 6-point scale |  | after 8 weeks | 
| Global assessment efficacy by investigator on 6-point scale |  | after 8 weeks |