Status:
UNKNOWN
Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Essential Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 hyperten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01413048
Start Date
January 1 2011
End Date
September 1 2012
Last Update
August 10 2011
Active Locations (1)
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1
The Catholic University of Korea-St. Mary's Hospital
Seoul, South Korea