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

This study is currently recruiting participants.
Verified August 2011 by Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor:
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01413048
First received: August 7, 2011
Last updated: August 8, 2011
Last verified: August 2011
History of Changes

August 7, 2011
August 8, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01413048 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
260
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
Both
19 Years and older
No
Contact: Sang-Young Yoon, Manager +82-2-3289-4257 syyoon@ahn-gook.com
Korea, Republic of
 
NCT01413048
1001AGCVSP3
Yes
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 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 Hospital
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