Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)
* Drug: Temisartan+Amlodipine
* Drug: Temisartan+Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Subjects with hypertension and hyperlipidemia Exclusion Criteria: Patients with known or suspected secondary hypertension Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination drug:Temisartan+Amlodipine+Rosuvastatin<br>60 subjects will be assigned and the subjects will be administered Temisartan+Amlodipine+Rosuvastatin for 8 weeks. | Drug: Temisartan+Amlodipine+Rosuvastatin (Combination drug)<br>* PO, Once daily(QD), 8weeks<br>* Other names: Twynsta Tab.+Crestor Tab.;|
| Active Comparator: Temisartan+Amlodipine<br>60 subjects will be assigned and the subjects will be administered Twynsta Tab.(Temisartan+Amlodipine) for 8 weeks. | Drug: Temisartan+Amlodipine<br>* PO, Once daily(QD), 8weeks<br>* Other names: Twynsta Tab.;|
| Active Comparator: Temisartan+Rosuvastatin<br>60 subjects will be assigned and the subjects will be administered Micardis Tab. and Crestor Tab.(Temisartan+Rosuvastatin) for 8 weeks. | Drug: Temisartan+Rosuvastatin<br>* PO, Once daily(QD), 8weeks<br>* Other names: Micardis Tab.+Crestor Tab.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |