- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01413048
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
Conditions
Intervention / Treatment
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
- Name: Sang-Young Yoon, Manager
- Phone Number: +82-2-3289-4257
- Email: syyoon@ahn-gook.com
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Carvedilol
Other Study ID Numbers
- 1001AGCVSP3
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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