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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH22162 | Experimental | 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 |
|
| telmisartan/amlodipine | Active Comparator | Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan/amlodipine 40/5mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | baseline and week 8 |
| 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 |
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Inclusion Criteria:
Signed Informed Consent
Men and women ≥ 19 years of age
Essential hypertensive patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyunhee Na, MD | Yuhan Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan | Seoul | South Korea |
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| 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 | Drug |
|
|
| 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| C548840 | telmisartan amlodipine combination |
| D002752 | Chlorthalidone |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
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