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A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin) |
|
| Reference 1 | Active Comparator | qd PO, Micardis(telmisartan) + Crestor(rosuvastatin) |
|
| Reference 2 | Active Comparator | qd PO,Twynsta(telmisartan/amlodipine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan + Amlodipine + Rosuvastatin | Drug | Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline | 8-week | |
| Change of LDL-C(Low Density Lipid Cholesterol) from baseline | 8-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sevrance Hospital | Seoul | South Korea |
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| Telmisartan + Amlodipine | Drug | Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo |
|
| Telmisartan + Rosuvastatin | Drug | Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D000068718 | Rosuvastatin Calcium |
| C548840 | telmisartan amlodipine combination |
| 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 |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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