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

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ClinicalTrials.gov Identifier: NCT01413048
Recruitment Status : Unknown
Verified August 2011 by Ahn-Gook Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : August 10, 2011
Last Update Posted : August 10, 2011
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Carvedilol 25mg Drug: AGSCT101 12.5mg Phase 3

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  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AGSCT101 Drug: AGSCT101 12.5mg
Tablet, q.d.
Active Comparator: Carvedilol Drug: Carvedilol 25mg
Tablet, q.d.

Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413048

Contact: Sang-Young Yoon, Manager +82-2-3289-4257 syyoon@ahn-gook.com

Korea, Republic of
The Catholic University of Korea-St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-bae Seung, Professor    +82-2-2258-1148      
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
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

Responsible Party: Woohyuk Jeong/Senior Researcher, Project Planning and Development Team
ClinicalTrials.gov Identifier: NCT01413048     History of Changes
Other Study ID Numbers: 1001AGCVSP3
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Essential Hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists