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Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.
This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.
In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks.
In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks.
In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Combination drug:Temisartan+Amlodipine+Rosuvastatin" | Experimental | 60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks. |
|
| Temisartan+Amlodipine | Active Comparator | 60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks. |
|
| Temisartan+Rosuvastatin | Active Comparator | 60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temisartan+Amlodipine+Rosuvastatin (Combination drug) | Drug | PO, Once daily(QD), 8weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change form the baseline at Week 8 | Baseline, Week 8 |
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change form the baseline at Week 8 | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| MSSBP (Mean sitting systolic blood pressure) | MSSBP change form the baseline at Week 4 | Baseline, Week 4 |
| Mean sitting diastolic blood pressure (MSDBP) | MSDBP change form the baseline at Week 4, 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyunhee Na, MD | Yuhan Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Natuional University Hospital | Seoul | Jongno | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32937023 | Derived | Jin X, Kim MH, Han KH, Hong SJ, Ahn JC, Sung JH, Cho JM, Lee HC, Choi SY, Lee K, Kim WS, Rhee MY, Kim JH, Hong SP, Yoo BS, Cho EJ, Lee JH, Kim PJ, Park CG, Hyon MS, Shin JH, Lee SH, Sung KC, Hwang J, Kwon K, Chae IH, Seo JS, Kim H, Lee H, Cho Y, Kim HS. Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. J Clin Hypertens (Greenwich). 2020 Oct;22(10):1835-1845. doi: 10.1111/jch.13893. Epub 2020 Sep 16. |
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Double Blind
| Temisartan+Amlodipine | Drug | PO, Once daily(QD), 8weeks |
|
|
| Temisartan+Rosuvastatin | Drug | PO, Once daily(QD), 8weeks |
|
|
| Baseline, Week 4, Week 8 |
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change form the baseline at Week 4 | Baseline, Week 4 |
| Total Cholesterol (TC) | TC change form the baseline at Week 4, 8 | Baseline, Week 4, Week 8 |
| High density lipoprotein cholesterol (HDL-C) | HDL-C change form the baseline at Week 4, 8 | Baseline, Week 4, Week 8 |
| Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) | LDL-C/HDL-C change form the baseline at Week 4, 8 | Baseline, Week 4, Week 8 |
| Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C) | TC/HDL-C change form the baseline at Week 4, 8 | Baseline, Week 4, Week 8 |
| Triglyceride (TG) | TG change form the baseline at Week 4, 8 | Baseline, Week 4, Week 8 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| C548840 | telmisartan amlodipine combination |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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