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The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan/Ezetimibe/Atorvastatin | Experimental | BR1017A+BR1017B(Experimental Group) |
|
| Fimasartan | Active Comparator | BR1017A(Control Group 2) |
|
| Ezetimibe/Atorvastatin | Active Comparator | BR1017B(Control Group 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | Subjects take the investigational products once a day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting systolic blood pressure | The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B | 8weeks from Baseline Visit |
| LDL-C | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A | 8weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B | 8weeks from Baseline Visit |
| Mean sitting systolic blood pressure | The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A |
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<Inclusion Criteria>
Screening
Randomization
Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3)
Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC)
Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2)
<Exclusion Criteria>
Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3)
Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
Patients with past history and comorbidities at screening(V1) under the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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| Ezetimibe/Atorvastatin | Drug | Subjects take the investigational products once a day for 8 weeks. |
|
|
| Fimasartan Placebo | Drug | Subjects take the investigational products once a day for 8 weeks. |
|
|
| Ezetimibe/Atorvastatin Placebo | Drug | Subjects take the investigational products once a day for 8 weeks. |
|
|
| 8weeks from Baseline Visit |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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