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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Ahn-Gook Pharmaceuticals Co.,Ltd.
Recruitment status was  Recruiting
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
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Drug: Carvedilol 25mg
Drug: AGSCT101 12.5mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 260
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGSCT101 Drug: AGSCT101 12.5mg
Tablet, q.d.
Active Comparator: Carvedilol Drug: Carvedilol 25mg
Tablet, q.d.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413048

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

Locations
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
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
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 Hospital
  More Information

No publications provided

Responsible Party: Woohyuk Jeong/Senior Researcher, Project Planning and Development Team
ClinicalTrials.gov Identifier: NCT01413048     History of Changes
Other Study ID Numbers: 1001AGCVSP3
Study First Received: August 7, 2011
Last Updated: August 8, 2011
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014