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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Ahn-Gook Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 10, 2011
Last Update Posted: August 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd
August 7, 2011
August 10, 2011
August 10, 2011
January 2011
March 2012   (Final data collection date for primary outcome measure)
Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 8 weeks ]
Same as current
No Changes Posted
  • Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 2 weeks ]
  • Change from baseline in systolic blood pressure (SBP) [ Time Frame: 2, 8 weeks ]
  • Proportion of patients who reach overall blood pressure control (defined as BP <140/90) [ Time Frame: 8 weeks ]
  • Incidence of adverse effects [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
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
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Carvedilol 25mg
    Tablet, q.d.
  • Drug: AGSCT101 12.5mg
    Tablet, q.d.
  • Experimental: AGSCT101
    Intervention: Drug: AGSCT101 12.5mg
  • Active Comparator: Carvedilol
    Intervention: Drug: Carvedilol 25mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Woohyuk Jeong/Senior Researcher, Project Planning and Development Team
Ahn-Gook Pharmaceuticals Co.,Ltd
Not Provided
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 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
Ahn-Gook Pharmaceuticals Co.,Ltd
August 2011

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