Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.
Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEWSTATIN TS | Active Comparator | Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg) |
|
| CADUET | Placebo Comparator | Dual therapy (Amlodipine + Atorvastatin 5/10mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEWSTATIN TS | Drug | Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in mean sitting systolic blood pressure (MSSBP) | Percent changes in MSSBP from baseline after 8 weeks of treatment | 8 weeks |
| Percent changes in LDL-C | Percent changes in LDL-C from baseline after 8 weeks of treatment | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in LDL-C | Percent changes in LDL-C from baseline after 4 weeks of treatment | 4 weeks |
| Percent changes in TC | Percent changes in TC from baseline after 4 and 8 weeks of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Chuncheon | Gangwon-do | 24289 | South Korea | ||
| Korea University Ansan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38380420 | Result | Park S, Hwang D, Kang J, Han JK, Yang HM, Park KW, Kang HJ, Koo BK, Cho JM, Cho BR, Ahn SG, Kang SM, Sung JH, Kim U, Lee N, Kim HS. Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial. Curr Ther Res Clin Exp. 2024 Feb 1;100:100735. doi: 10.1016/j.curtheres.2024.100735. eCollection 2024. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487936 | amlodipine, atorvastatin drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CADUET | Drug | Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks |
|
|
| 4, 8weeks |
| Percent changes in TG | Percent changes in TG from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| Percent changes in HDL-C | Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| Percent changes in Non-HDL-C | Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement | 4, 8weeks |
| Percent changes in Apo B | Percent changes in Apo B from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| Percent changes in Apo A-I | Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| Percent changes in LDL-C/HDL-C ratio | Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement | 4, 8weeks |
| Percent changes in Apo B/Apo A-I ratio | Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| Percent changes in hs-CRP | Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment | 4, 8weeks |
| The percentage of patients achieving treatment goal for blood pressure and LDL-C | The percentage of patients achieving treatment goal for blood pressure and LDL-C | 8 weeks |
| Changes in mean sitting systolic/diastolic blood pressure | Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment | 4, 8weeks |
| Ansan |
| Gyeonggi-do |
| 15355 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 14068 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | South Korea |
| D009750 | Nutritional and Metabolic Diseases |