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

Ahn-Gook Pharmaceuticals

Status and phase

Unknown

Phase 3

Conditions

Essential Hypertension

Treatments

Drug: AGSCT101 12.5mg

Drug: Carvedilol 25mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01413048

1001AGCVSP3

Details and patient eligibility

About

The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.

Full 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.

Enrollment

260 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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