A Phase 3 interventional study of Temisartan+Amlodipine+Rosuvastatin (Combination drug) and Temisartan+Amlodipine in Hypertension and Hyperlipidemia, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Yuhan Corporation · Phase 3, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 202 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)
60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
Drug: Temisartan+Amlodipine
60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
Drug: Temisartan+Rosuvastatin
PO, Once daily(QD), 8weeks
Also known as: Twynsta Tab.+Crestor Tab.
PO, Once daily(QD), 8weeks
Also known as: Twynsta Tab.
PO, Once daily(QD), 8weeks
Also known as: Micardis Tab.+Crestor Tab.
Mean sitting systolic blood pressure (MSSBP)
MSSBP change form the baseline at Week 8
Time frame: Baseline, Week 8
Low density lipoprotein cholesterol (LDL-C)
LDL-C change form the baseline at Week 8
Time frame: Baseline, Week 8
MSSBP (Mean sitting systolic blood pressure)
MSSBP change form the baseline at Week 4
Time frame: Baseline, Week 4
Mean sitting diastolic blood pressure (MSDBP)
MSDBP change form the baseline at Week 4, 8
Time frame: Baseline, Week 4, Week 8
Low density lipoprotein cholesterol (LDL-C)
LDL-C change form the baseline at Week 4
Time frame: Baseline, Week 4
Total Cholesterol (TC)
TC change form the baseline at Week 4, 8
Time frame: Baseline, Week 4, Week 8
High density lipoprotein cholesterol (HDL-C)
HDL-C change form the baseline at Week 4, 8
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 4, Week 8
Triglyceride (TG)
TG change form the baseline at Week 4, 8
Time frame: Baseline, Week 4, Week 8
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Yuhan Corporation