Clinical trial NCT01413048: Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension
Official title: Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Hypertension
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 260
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change from baseline in diastolic blood pressure (DBP)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure (DBP)
timeFrame: 2 weeks
measure: Change from baseline in systolic blood pressure (SBP)
timeFrame: 2, 8 weeks
measure: Proportion of patients who reach overall blood pressure control (defined as BP <140/90)
timeFrame: 8 weeks
measure: Incidence of adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea-St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea-St. Mary's Hospital
name: Ki-Bae Seung, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Hun-Sik Park, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Chang-Gyu Park, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongguk University Medical Center
name: Moo-Yong Rhee, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Dong-Ju Choi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Seung-Jea Tahk, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Christian Hospital
name: Jung-Han Yoon, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Sung-Ha Park, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Myung-Ho Jeong, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Sang-Wook Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: