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:
Ahn-Gook Pharmaceuticals Co.,Ltd
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
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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
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 | 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 |
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 Vascular Diseases Cardiovascular Diseases Carvedilol Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions 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 |
ClinicalTrials.gov processed this record on June 17, 2013