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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01413048

Enrollment

260

Registered

2011-08-10

Start date

2011-01-31

Completion date

2012-09-30

Last updated

2011-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Essential Hypertension, Hypertension

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.

Interventions

DRUGCarvedilol 25mg

Tablet, q.d.

DRUGAGSCT101 12.5mg

Tablet, q.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic blood pressure (DBP)	8 weeks

Secondary

Measure	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

Countries

South Korea

Contacts

Primary ContactSang-Young Yoon, Manager

syyoon@ahn-gook.com+82-2-3289-4257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026