Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.

Detailed Description
-----------------
This study is 2,8 weeks, multi-center, randomized, double-blind, active clinical trial to evaluate the efficacy and safety of AGSCT101 versus Carvedilol in patient with stage 1 to 2 essential hypertension.

Official Title
-----------------
Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Carvedilol 25mg
* Drug: AGSCT101 12.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients ≥ 19 years of age Mild to moderate essential hypertension: sDBP 90   109, sSBP 140   179 Subjects who agree to participate in this sudy and give written informed consent Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Exclusion Criteria: The sitting DBP is more than 110mmHg or the sitting SBP over 180mmHg Patients with postural hypotension Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 3 times more than upper limit of normal)disease Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal Patients judged to have a history of alcohol or drug abuse by the investigator Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months Patients with uncontrolled diabetes mellitus Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons

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: AGSCT101<br> | Drug: AGSCT101 12.5mg<br>* Tablet, q.d.<br>|
| Active Comparator: Carvedilol<br> | Drug: Carvedilol 25mg<br>* Tablet, q.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure (DBP) |  | 2 weeks | 
| Change from baseline in systolic blood pressure (SBP) |  | 2, 8 weeks | 
| Proportion of patients who reach overall blood pressure control (defined as BP <140/90) |  | 8 weeks | 
| Incidence of adverse effects |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential Hypertension, Hypertension