Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

Study Overview
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Brief Summary
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To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment

Official Title
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A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan/amlodipine 40/5mg
* Drug: YH22162 40/5/12.5 mg
* Drug: telmisartan/amlodipine 80/5mg
* Drug: YH22162 80/5/25 mg
* Drug: telmisartan/amlodipine 40/5mg placebo
* Drug: YH22162 40/5/12.5 mg placebo
* Drug: telmisartan/amlodipine 80/5mg placebo
* Drug: YH22162 80/5/25 mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Men and women ≥ 19 years of age Essential hypertensive patients If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg Exclusion Criteria: Patients with known or suspected secondary hypertension Other exclusions applied

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: YH22162<br>YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks | Drug: YH22162 40/5/12.5 mg<br> <br> * Other names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg;Drug: YH22162 80/5/25 mg<br> <br> * Other names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg;Drug: telmisartan/amlodipine 40/5mg placebo<br> <br> * Other names: Twynsta 40/5 mg placebo;Drug: telmisartan/amlodipine 80/5mg placebo<br> <br> * Other names: Twynsta 80/5 mg;|
| Active Comparator: telmisartan/amlodipine<br>Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks | Drug: telmisartan/amlodipine 40/5mg<br> <br> * Other names: Twynsta 40/5 mg;Drug: telmisartan/amlodipine 80/5mg<br> <br> * Other names: Twynsta 80/5 mg;Drug: YH22162 40/5/12.5 mg placebo<br> <br> * Other names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo;Drug: YH22162 80/5/25 mg placebo<br> <br> * Other names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 |  | baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 |  | baseline and week 2 | 
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 |  | baseline and week 4 | 
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2 |  | baseline and week 2 | 
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4 |  | baseline and week 4 | 
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8 |  | baseline and week 8 | 
| Patients Achieving Blood Pressure Control at Week 2 | Mean sitting blood pressure(MSBP) < 140/90 mmHg | baseline and week 2 | 
| Patients Achieving Blood Pressure Control at Week 4 | Mean sitting blood pressure(MSBP) < 140/90 mmHg | baseline and week 4 | 
| Patients Achieving Blood Pressure Control at Week 8 | Mean sitting blood pressure(MSBP) < 140/90 mmHg | baseline and week 8 | 
| Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2 | reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg | baseline and week 2 | 
| Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4 | reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg | baseline and week 4 | 
| Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8 | reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg | baseline and week 8 |