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

Essential Hypertension Clinical Trial

Official title:

Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01413048
• Other study ID #: 1001AGCVSP3
• Status: Recruiting
• Phase: Phase 3
• First received: August 7, 2011
• Last updated: August 8, 2011
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: Sang-Young Yoon, Manager
• Phone: +82-2-3289-4257
• Email: syyoon[@]ahn-gook.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Carvedilol 25mg
Tablet, q.d.
• AGSCT101 12.5mg
Tablet, q.d.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea-St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in diastolic blood pressure (DBP)		8 weeks	No
Secondary	Change from baseline in diastolic blood pressure (DBP)		2 weeks	No
Secondary	Change from baseline in systolic blood pressure (SBP)		2, 8 weeks	No
Secondary	Proportion of patients who reach overall blood pressure control (defined as BP <140/90)		8 weeks	No
Secondary	Incidence of adverse effects		8 weeks	Yes