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To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH16410 | Experimental | PO, Once Daily, 8 weeks |
|
| Rosuvastatin | Active Comparator | PO, Once Daily, 8 weeks |
|
| Telmisartan | Active Comparator | PO, Once Daily, 8 weeks |
|
| Placebo | Placebo Comparator | PO, Once Daily, 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH16410 | Drug |
| ||
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure, Change in LDL Cholesterol | Change from Baseline at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Su Youn Nam, MD | Yuhan Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29673890 | Derived | Oh GC, Han JK, Han KH, Hyon MS, Doh JH, Kim MH, Jeong JO, Bae JH, Kim SH, Yoo BS, Baek SH, Rhee MY, Ihm SH, Sung JH, Choi YJ, Kim SJ, Hong KS, Lee BK, Cho J, Shin ES, Rhew JY, Kim H, Kim HS. Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clin Ther. 2018 May;40(5):676-691.e1. doi: 10.1016/j.clinthera.2018.03.010. Epub 2018 Apr 17. |
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|
| Telmisartan | Drug |
|
| YH16410 placebo | Drug |
|
| Rosuvastatin placebo | Drug |
|
| Telmisartan placebo | Drug |
|
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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