NCT01413048Unknown3 期
Phase III Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 Versus Carvedilol in Patient With Stage 1 to 2 Essential Hypertension
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change from baseline in diastolic blood pressure (DBP)
研究概览
简要总结
The purpose of this study is to evaluate the antihypertensive effect of AGSCT101 tablet in patient with stage 1 to 2 essential hypertension.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
AGSCT101
Experimental
干预措施: AGSCT101 12.5mg (Drug)
Carvedilol
Active Comparator
干预措施: Carvedilol 25mg (Drug)
结局指标
主要结局
Change from baseline in diastolic blood pressure (DBP)
时间窗: 8 weeks
次要结局
- Change from baseline in diastolic blood pressure (DBP)(2 weeks)
- Change from baseline in systolic blood pressure (SBP)(2, 8 weeks)
- Proportion of patients who reach overall blood pressure control (defined as BP <140/90)(8 weeks)
- Incidence of adverse effects(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-RelatedHepatitis B Virus Related Hepatocellular CarcinomaHepatocellular CarcinomaHCCNCT06617000SCG Cell Therapy Pte. Ltd.38
已完成
2 期
A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.Chronic Heart FailureNCT04515290Shanghai Hongyitang Biopharmaceutical Technology Co. Ltd.85
招募中
3 期
Study to Evaluate GR1801's Efficacy and SafetyRabies Post-exposure ProphylaxisNCT05846568Genrix (Shanghai) Biopharmaceutical Co., Ltd.1,200
终止
2 期
ATX-101 in Advanced Dedifferentiated Liposarcoma and LeiomyosarcomaLeiomyosarcomaLiposarcomaNCT05116683Benjamin Izar4
已完成
3 期
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic CougherCoughNCT00380315Ahn-Gook Pharmaceuticals Co.,Ltd396