Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.

Conditions
-----------------
Hypertension, Cholesterolemia

Intervention / Treatment
-----------------
* Drug: DP-R208
* Drug: Candesartan32mg
* Drug: Rosuvastatin 20mg
* Drug: DP-R208 Placebo
* Drug: Candesartan32mg Placebo
* Drug: Rosuvastatin 20mg Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both man and woman who is over 19years old. Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL Exclusion Criteria: Therapeutic lifestylechange is not enought during the study period SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit

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: CR group<br>DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla | Drug: DP-R208<br>* DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo<br>Drug: Candesartan32mg Placebo<br>* DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg<br>Drug: Rosuvastatin 20mg Placebo<br>* DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo<br>|
| Active Comparator: CP group<br>DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla | Drug: Candesartan32mg<br>* DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo<br>* Other names: Candesartan;Drug: DP-R208 Placebo<br>* DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg<br>Drug: Rosuvastatin 20mg Placebo<br>* DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo<br>|
| Active Comparator: PR group<br>DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg | Drug: Rosuvastatin 20mg<br>* DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg<br>* Other names: Rosuvastatin;Drug: DP-R208 Placebo<br>* DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg<br>Drug: Candesartan32mg Placebo<br>* DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol |  | 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R208