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

NCT ID: NCT01413048

Last Updated: 2011-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGSCT101

Group Type EXPERIMENTAL

AGSCT101 12.5mg

Intervention Type DRUG

Tablet, q.d.

Carvedilol

Group Type ACTIVE_COMPARATOR

Carvedilol 25mg

Intervention Type DRUG

Tablet, q.d.

Interventions

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Carvedilol 25mg

Tablet, q.d.

Intervention Type DRUG

AGSCT101 12.5mg

Tablet, q.d.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Project Planning and Development Team

Principal Investigators

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Ki-Bae Seung, Professor

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea-St. Mary's Hospital

Hun-Sik Park, Professor

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Chang-Gyu Park, Professor

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Moo-Yong Rhee, Professor

Role: PRINCIPAL_INVESTIGATOR

Dongguk University Medical Center

Dong-Ju Choi, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Seung-Jea Tahk, Professor

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Jung-Han Yoon, Professor

Role: PRINCIPAL_INVESTIGATOR

Wonju Christian Hospital

Sung-Ha Park, Professor

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Myung-Ho Jeong, Professor

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Sang-Wook Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

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The Catholic University of Korea-St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-Young Yoon, Manager

Role: CONTACT

+82-2-3289-4257

Facility Contacts

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Ki-bae Seung, Professor

Role: primary

+82-2-2258-1148

Other Identifiers

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1001AGCVSP3

Identifier Type: -

Identifier Source: org_study_id

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