A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
试验速览
- 阶段
- 3 期
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- •Change in seated diastolicblood pressure at 8 weeks compared to the base value
研究概览
简要总结
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Men and women >18 years of age
- •Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent
排除标准
- •Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
- •Other exclusions applied
研究组 & 干预措施
Telmisartan 80mg & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Telmisartan 80mg (Drug)
Telmisartan 80mg & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin 20mg (Drug)
Telmisartan 80mg & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 10mg) (Drug)
Telmisartan 80mg & Rosuvastatin 10mg
PO, Once Daily, 8weeks
干预措施: Telmisartan 80mg (Drug)
Telmisartan 80mg & Rosuvastatin 10mg
PO, Once Daily, 8weeks
干预措施: Rosuvastatin 10mg (Drug)
Telmisartan 80mg & Rosuvastatin 10mg
PO, Once Daily, 8weeks
干预措施: Placebo(for Rosuvastatin 20mg) (Drug)
Telmisartan placebo & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin 20mg (Drug)
Telmisartan placebo & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Placebo(for Telmisartan 80mg) (Drug)
Telmisartan placebo & Rosuvastatin 20mg
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 10mg) (Drug)
Telmisartan Placebo & Rosuvastatin 10mg
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin 10mg (Drug)
Telmisartan Placebo & Rosuvastatin 10mg
PO, Once Daily, 8 weeks
干预措施: Placebo(for Telmisartan 80mg) (Drug)
Telmisartan Placebo & Rosuvastatin 10mg
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 20mg) (Drug)
Telmisartan 80mg & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Telmisartan 80mg (Drug)
Telmisartan 80mg & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Placebo(for Telmisartan 80mg) (Drug)
Telmisartan 80mg & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 20mg) (Drug)
Telmisartan placebo & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Placebo(for Telmisartan 80mg) (Drug)
Telmisartan placebo & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 20mg) (Drug)
Telmisartan placebo & Rosuvastatin placebo
PO, Once Daily, 8 weeks
干预措施: Placebo(for Rosuvastatin 10mg) (Drug)
结局指标
主要结局
•Change in seated diastolicblood pressure at 8 weeks compared to the base value
时间窗: at the 8 weeks
Change in LDL-Cat 8 weeks compared to the base value (% change)
时间窗: at the 8 weeks
次要结局
- Change in seateddiastolic blood pressure(at 2,4 8 weeks)
- Change in seated systolic blood pressure(at 2,4,8weeks)
- Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)](at 2, 4 and 8 weeks)
- Change in LDL-Cat compared to the base value (% change)(2, 4 and 8 weeks)
- Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)(at 2, 4 and 8 weeks)
- Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)(at 2, 4 and 8 weeks)