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

Tracking Information

First Received Date ^ICMJE

August 7, 2011

Last Updated Date

August 8, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01413048 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Change from baseline in systolic blood pressure (SBP) [ Time Frame: 2, 8 weeks ] [ Designated as safety issue: No ]
Proportion of patients who reach overall blood pressure control (defined as BP <140/90) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Incidence of adverse effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: Carvedilol 25mg
Tablet, q.d.
Drug: AGSCT101 12.5mg
Tablet, q.d.

Study Arms

Experimental: AGSCT101
Intervention: Drug: AGSCT101 12.5mg
Active Comparator: Carvedilol
Intervention: Drug: Carvedilol 25mg

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

260

Estimated Completion Date

September 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sang-Young Yoon, Manager

+82-2-3289-4257

syyoon@ahn-gook.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01413048

Other Study ID Numbers ^ICMJE

1001AGCVSP3

Has Data Monitoring Committee

Yes

Responsible Party

Woohyuk Jeong/Senior Researcher, Project Planning and Development Team

Study Sponsor ^ICMJE

Ahn-Gook Pharmaceuticals Co.,Ltd

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Ki-Bae Seung, Professor	The Catholic University of Korea-St. Mary's Hospital
Principal Investigator:	Hun-Sik Park, Professor	Kyungpook National University
Principal Investigator:	Chang-Gyu Park, Professor	Korea University Guro Hospital
Principal Investigator:	Moo-Yong Rhee, Professor	Dongguk University Medical Center
Principal Investigator:	Dong-Ju Choi, Professor	Seoul National University Bundang Hospital
Principal Investigator:	Seung-Jea Tahk, Professor	Ajou University School of Medicine
Principal Investigator:	Jung-Han Yoon, Professor	Yonsei University
Principal Investigator:	Sung-Ha Park, Professor	Severance Hospital
Principal Investigator:	Myung-Ho Jeong, Professor	Chonnam National University Hospital
Principal Investigator:	Sang-Wook Kim, Professor	Chung-Ang University

Information Provided By

Ahn-Gook Pharmaceuticals Co.,Ltd

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP