Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients

Study Overview
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Brief Summary
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Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination

Official Title
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Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients Not Controlled by Telmisartan/Amlodipine Combination

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Telmisartan/Amlodipine+Hydrochlorothiazide
* Drug: Telmisartan/Amlodipine
* Drug: Placebo for Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years old or above Koreans living in Korea Patients with uncontrolled essential hypertension at screening time(Visit 1) Naïve: 160 mmHg ≤ sitSBP < 200 mmHg Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2) - 140 mmHg ≤ sitSBP < 200 mmHg Patients who agreed to participate in the trial Exclusion Criteria: Test results showing the following values at screening time(Visit 1) The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma) -Patients with congestive heart failure(NYHA class III IV) Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9% Patients who have history of severe or malignant retinopathy within 6 months prior to study entry Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT > 2.5 times of upper limit of normal range) Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators) Patients who should be administered medications prohibited for concomitant use during study period Patients who are dependent on drugs or alcohol Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion Patients with hypersensitivity to the components of investigational drug. Patients with hypersensitivity to Sulfonamide Patients with anuria Patients with hypercalcemia, hyponatremia/hypokalemia Patients with Addison's disease Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy History of malignant tumor including leukemia, lymphoma within 5 years Patients taking other clinical trial drugs within 30 days from the time of visit for screening Pregnancy, breast-feeding, or child-bearing potential Patients Patients who are judged unsuitable to participate in this study by investigator

Ages Eligible for Study
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Minimum Age: 19 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan/Amlodipine+Hydrochlorothiazide<br>Telmisartan/Amlodipine combination drug and Hydrochlorothiazide | Drug: Telmisartan/Amlodipine+Hydrochlorothiazide<br>* Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD<br>|
| Active Comparator: Telmisartan/Amlodipine<br>Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide | Drug: Telmisartan/Amlodipine<br>* Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD<br>Drug: Placebo for Hydrochlorothiazide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of sitting systolic blood pressure |  | From baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of sitting systolic blood pressure |  | From baseline at week 2 | 
| The change of sitting diastolic blood pressure |  | From baseline at week 2 and 8 | 
| The ratio of subjects who get normalized blood pressure |  | at week 2 and 8 | 
| Response Rate |  | at week 2 and 8 |