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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
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
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
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Percent changes in mean sitting systolic blood pressure (MSSBP)
Percent changes in MSSBP from baseline after 8 weeks of treatment
Time frame: 8 weeks
Percent changes in LDL-C
Percent changes in LDL-C from baseline after 8 weeks of treatment
Time frame: 8 weeks
Percent changes in LDL-C
Percent changes in LDL-C from baseline after 4 weeks of treatment
Time frame: 4 weeks
Percent changes in TC
Percent changes in TC from baseline after 4 and 8 weeks of treatment
Time frame: 4, 8weeks
Percent changes in TG
Percent changes in TG from baseline after 4 and 8 weeks of treatment
Time frame: 4, 8weeks
Percent changes in HDL-C
Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment
Time frame: 4, 8weeks
Percent changes in Non-HDL-C
Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement
Time frame: 4, 8weeks
Percent changes in Apo B
Percent changes in Apo B from baseline after 4 and 8 weeks of treatment
Time frame: 4, 8weeks
Percent changes in Apo A-I
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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Yeungnam University Hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 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
Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: 4, 8weeks
Percent changes in hs-CRP
Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: 4, 8weeks