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

Primary Purpose

Essential Hypertension

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Carvedilol 25mg

AGSCT101 12.5mg

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential Hypertension, Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AGSCT101

Carvedilol

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in diastolic blood pressure (DBP)

Secondary Outcome Measures

Change from baseline in diastolic blood pressure (DBP)

Change from baseline in systolic blood pressure (SBP)

Proportion of patients who reach overall blood pressure control (defined as BP <140/90)

Incidence of adverse effects

Full Information

NCT ID

NCT01413048

First Posted

August 7, 2011

Last Updated

August 8, 2011

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01413048

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

Essential Hypertension, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AGSCT101

Arm Type

Experimental

Arm Title

Carvedilol

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Carvedilol 25mg

Intervention Description

Tablet, q.d.

Intervention Type

Drug

Intervention Name(s)

AGSCT101 12.5mg

Intervention Description

Tablet, q.d.

Primary Outcome Measure Information:

Title

Change from baseline in diastolic blood pressure (DBP)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in diastolic blood pressure (DBP)

Time Frame

2 weeks

Title

Change from baseline in systolic blood pressure (SBP)

Time Frame

2, 8 weeks

Title

Proportion of patients who reach overall blood pressure control (defined as BP <140/90)

Time Frame

8 weeks

Title

Incidence of adverse effects

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang-Young Yoon, Manager

Phone

+82-2-3289-4257

syyoon@ahn-gook.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ki-Bae Seung, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hun-Sik Park, Professor

Organizational Affiliation

Kyungpook National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chang-Gyu Park, Professor

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Moo-Yong Rhee, Professor

Organizational Affiliation

Dongguk University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dong-Ju Choi, Professor

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seung-Jea Tahk, Professor

Organizational Affiliation

Ajou University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jung-Han Yoon, Professor

Organizational Affiliation

Wonju Christian Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sung-Ha Park, Professor

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Myung-Ho Jeong, Professor

Organizational Affiliation

Chonnam National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sang-Wook Kim, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ki-bae Seung, Professor

Phone

+82-2-2258-1148

12. IPD Sharing Statement

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

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