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

August 8, 2011 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd

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

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

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea-St. Mary's Hospital
        • Contact:
          • Ki-bae Seung, Professor
          • Phone Number: +82-2-2258-1148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGSCT101
Tablet, q.d.
Active Comparator: Carvedilol
Tablet, q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in diastolic blood pressure (DBP)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in diastolic blood pressure (DBP)
Time Frame: 2 weeks
2 weeks
Change from baseline in systolic blood pressure (SBP)
Time Frame: 2, 8 weeks
2, 8 weeks
Proportion of patients who reach overall blood pressure control (defined as BP <140/90)
Time Frame: 8 weeks
8 weeks
Incidence of adverse effects
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ki-Bae Seung, Professor, The Catholic University of Korea-St. Mary's Hospital
  • Principal Investigator: Hun-Sik Park, Professor, Kyungpook National University Hospital
  • Principal Investigator: Chang-Gyu Park, Professor, Korea University Guro Hospital
  • Principal Investigator: Moo-Yong Rhee, Professor, Dongguk University Medical Center
  • Principal Investigator: Seung-Jea Tahk, Professor, Ajou University School of Medicine
  • Principal Investigator: Jung-Han Yoon, Professor, Wonju Christian Hospital
  • 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 Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

August 7, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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