NCT03566316已完成3 期
Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Percentage of change in LDL-Cholesterol
研究概览
简要总结
A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia
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
- •19 years old or above
- •Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL)
- •Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator
- •Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure >140mmHg
- •Test results showing the following values at screening time (Visit 2) : 100< LDL-Cholesterol <250
- •Patients who agreed to participate in the trial
排除标准
- •Severe hypertension patients(systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)
- •The change of mean sit systolic blood pressure ≥ 20 mmHg or sit diastolic blood pressure ≥ 10 mmHg on target arm between 1st and 2nd measurement
- •LDL-Cholesterol > 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1)
- •Patients with postural hypotension who have sign and symptom
- •Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases)
- •Patients with congestive heart failure(New York Heart Association class III~IV)
- •Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months
- •Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
- •Causes of hemodynamic disorder or structural heart defect such as valvular heart disease
- •Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
- •Patients with primary aldosteronism
- •Patients with severe ocular disorders
- •Patients with autoimmune disease
- •Patients with any chronic inflammation disease needed to chronic inflammation therapy
- •Patients with uncontrolled diabetes Mellitus with HbA1c > 9% or thyroid diseases(TSH ≥ 1.5 X ULN)
- •Patients who have a history of myopathy or rhabdomyolysis
- •Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK)
- •History of malignant tumor including leukemia, lymphoma within 5 years
- •Patients with one kidney
- •Patients with biliary obstructive disorder
- •Patients with clinically significant electrolyte disturbance
- •Continued serum potassium concentration abnormal status (<3.5mEq/L or >5.5mEq/L)
- •Patients with sodium ion or body fluid is depleted and not able to correct
- •Patients with clinically significant liver/renal disease
- •Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery
- •Patients who are dependent on drugs or alcohol
- •Pregnancy, breast-feeding, or child-bearing potential Patients
- •Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers
- •Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs
- •Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate
- •Patients who are unable to stop taking prohibited drugs to combination during study period
- •Patients who have galactose intolerance
- •Patients taking other clinical trial drugs within 30 days from the time of visit for screening
- •Patients that is not eligible to participate at the discretion of study investigator
研究组 & 干预措施
Telmisartan/Amlodipine+Rosuvastatin
Experimental
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
干预措施: Telmisartan/Amlodipine (Drug)
Telmisartan/Amlodipine+Rosuvastatin
Experimental
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.
干预措施: Rosuvastatin (Drug)
Telmisartan/Amlodipine
Active Comparator
Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.
干预措施: Telmisartan/Amlodipine (Drug)
Telmisartan +Rosuvastatin
Active Comparator
Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
干预措施: Rosuvastatin (Drug)
Telmisartan +Rosuvastatin
Active Comparator
Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.
干预措施: Telmisartan (Drug)
结局指标
主要结局
Percentage of change in LDL-Cholesterol
时间窗: From baseline at week 8
Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine
The change of sitting systolic blood pressure
时间窗: From baseline at week 8
Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin
次要结局
- The change of sitting diastolic blood pressure(From baseline at week 4 and 8)
- The change of HDL-Cholesterol/LDL-Cholesterol ratio(From baseline at week 4 and 8)
- Percentage of change in LDL-Cholesterol(From baseline at week 4)
- Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B(From baseline at week 4 and 8)
- The change of total cholesterol/HDL-Cholesterol ratio(From baseline at week 4 and 8)
- Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline(From baseline at week 4 and 8)
- Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline(From baseline at week 4 and 8)
研究者
研究点 (1)
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