A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.
研究概览
简要总结
This is a Randomized, open-label, 2 groups, parallel design.
详细描述
This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.
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
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 79 years old at screening visit
- •Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
- •Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least
- •Abdominal obesity: Waist measurement > 90 cm(male), > 80 cm(female)
- •Triglyceride(TG) ≥ 150 mg/dL(
- •High-Density Lipoprotein Cholesterol(HDL-C) < 40 mg/dL(male), < 50 mg/dL (female)
- •Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents
- •Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
- •Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.
排除标准
- •Subjects who taking anti-hypertension drugs more than three agent
- •Subjects who have mean Sitting Systolic Blood Pressure(siSBP) > 160 mmHg (excluded if appliable, one of the arms)
- •Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
- •Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
- •Subjects who have triglyceride (TG) ≥ 400mg/dL
- •Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms.
- •Other exclusions applied
研究组 & 干预措施
Telmisartan+Rosuvastatin
Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks
* But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
干预措施: Telmisartan 40mg + Rosuvastatin 20mg (Drug)
Telmisartan+Rosuvastatin
Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks
* But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
干预措施: Telmisartan 80mg + Rosuvastatin 20mg (Drug)
Telmisartan/Rosuvastatin
Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks
* But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
干预措施: Telmisartan 40mg, 80 mg (Drug)
Telmisartan/Rosuvastatin
Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks
* But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit.
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration.
时间窗: week 8
次要结局
- Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks(From baseline to 4 and 8 weeks)
- Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks(From baseline to 4 and 8 weeks)
- Change of below indicators from baseline to 4 and 8 weeks(baseline to 4 and 8 weeks)
- The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks(4 and 8 weeks)
- The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks(4 and 8 weeks)