A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 9
- 主要终点
- Percent changes in LDL-C
研究概览
简要总结
The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.
详细描述
Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •145 mmHg ≤ msSBP ≤ 190 mmHg
- •Triglycerides < 500 mg/dL
- •LDL-C ≤ 250 mg/dL
排除标准
- •sSBP ≥ 20mmHg and sDBP ≥ 10mmHg
- •symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia
- •history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)
- •hypersensitivity to telmisartan or rosuvastatin
- •history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal
- •estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal
- •potassium levels >5.5 mmol/L; or any diseases that could affect the results of the study.
研究组 & 干预措施
NEWSTATIN TS
Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)
干预措施: NEWSTATIN TS (Drug)
CADUET
Dual therapy (Amlodipine + Atorvastatin 5/10mg)
干预措施: CADUET (Drug)
结局指标
主要结局
Percent changes in LDL-C
时间窗: 8 weeks
Percent changes in LDL-C from baseline after 8 weeks of treatment
Percent changes in mean sitting systolic blood pressure (MSSBP)
时间窗: 8 weeks
Percent changes in MSSBP from baseline after 8 weeks of treatment
次要结局
- Percent changes in TG(4, 8weeks)
- Percent changes in LDL-C(4 weeks)
- Percent changes in HDL-C(4, 8weeks)
- Percent changes in Non-HDL-C(4, 8weeks)
- Percent changes in Apo B(4, 8weeks)
- Percent changes in hs-CRP(4, 8weeks)
- Changes in mean sitting systolic/diastolic blood pressure(4, 8weeks)
- Percent changes in TC(4, 8weeks)
- Percent changes in Apo A-I(4, 8weeks)
- Percent changes in LDL-C/HDL-C ratio(4, 8weeks)
- Percent changes in Apo B/Apo A-I ratio(4, 8weeks)
- The percentage of patients achieving treatment goal for blood pressure and LDL-C(8 weeks)
研究者
Hyo-Soo Kim
Director, Coronary Intervention & Transcatheter Aortic Valve Implantation
Seoul National University Hospital