The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy

Study Overview
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Brief Summary
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A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy

Official Title
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A Multi-center, Randomized, Double-blind, Phase IV Clinical Trial to Compare the Efficacy and Safety of OROSARTAN® Tablet 5/160mg Versus CODIOVAN® Tablet 160/12.5mg in Patients With Essential Hypertension Uncontrolled With Valsartan 160mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: OROSARTAN® 5/160mg
* Drug: CODIOVAN® 160/12.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 aged or over A patient who was diagnosed with essential hypertension at screening(Visit 1) A patient understood objective of this clinical trial and gave their written informed consent voluntarily Exclusion Criteria: A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1 A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation Medical history or evidence of a secondary form of hypertension A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine orotate & Valsartan<br>Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks | Drug: OROSARTAN® 5/160mg<br> <br> |
| Active Comparator: Valsartan & Hydrochlorothiazide<br>Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks | Drug: CODIOVAN® 160/12.5mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSDBP |  | Baseline, Week 4 | 
| Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP) |  | Baseline, Week 4 and 8 | 
| Control rate in blood pressure | Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg) | Baseline, Week 8 | 
| Responder rate in blood pressure | Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline | Baseline, Week 8 |