A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia
Overview
- Phase
- Phase 3
- Intervention
- Temisartan+Amlodipine+Rosuvastatin (Combination drug)
- Conditions
- Hypertension
- Sponsor
- Yuhan Corporation
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Mean sitting systolic blood pressure (MSSBP)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Subjects with hypertension and hyperlipidemia
Exclusion Criteria
- •Patients with known or suspected secondary hypertension
- •Other exclusions applied
Arms & Interventions
"Combination drug:Temisartan+Amlodipine+Rosuvastatin"
60 subjects will be assigned and the subjects will be administered "Temisartan+Amlodipine+Rosuvastatin" for 8 weeks.
Intervention: Temisartan+Amlodipine+Rosuvastatin (Combination drug)
Temisartan+Amlodipine
60 subjects will be assigned and the subjects will be administered "Twynsta Tab.(Temisartan+Amlodipine)" for 8 weeks.
Intervention: Temisartan+Amlodipine
Temisartan+Rosuvastatin
60 subjects will be assigned and the subjects will be administered "Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin)" for 8 weeks.
Intervention: Temisartan+Rosuvastatin
Outcomes
Primary Outcomes
Mean sitting systolic blood pressure (MSSBP)
Time Frame: Baseline, Week 8
MSSBP change form the baseline at Week 8
Low density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Week 8
LDL-C change form the baseline at Week 8
Secondary Outcomes
- MSSBP (Mean sitting systolic blood pressure)(Baseline, Week 4)
- High density lipoprotein cholesterol (HDL-C)(Baseline, Week 4, Week 8)
- Mean sitting diastolic blood pressure (MSDBP)(Baseline, Week 4, Week 8)
- Low density lipoprotein cholesterol (LDL-C)(Baseline, Week 4)
- Total Cholesterol (TC)(Baseline, Week 4, Week 8)
- Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)(Baseline, Week 4, Week 8)
- Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)(Baseline, Week 4, Week 8)
- Triglyceride (TG)(Baseline, Week 4, Week 8)