KCT0000963招募中未知
Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared with Atorvastatin in Mixed Hypercholesterolemic Patient: Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study
Chong Kun Dang0 个研究点目标入组 476 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 476
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. 19 years old and above
- •2. High risk patient to Coronary Heart Disease
- •(applied to 1 or more CHD risk factor listed below)
- •a.Patient with Coronary Heart Disease
- •b.Patient with carotid artery disease, peripheral blood vessel
- •disease, abdominal aneurysm
- •c.Patient with diabetes(HbA1C=8.0%)
- •d.10-year risk of CHD >20%
- •(by Framingham 10-year risk score calculation)
- •3. At Visit 1(Screening)
- •a.If not treated with Atorvastatin 20mg monotherapy without the change of dosage for 4 weeks and LDL-C=130mg/dl, 150mg/dl=TG=400mg/dl
- •: 4weeks of Atorvastatin 20mg monotherapy run-in period
- •b.If treated with Atorvastatin 20mg monotherapy without the change of dosage for 4 weeks prior to this study and LDL-C<100mg/dl, 150mg/dl=TG=400mg/dl
- •: Randomization
- •4. At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)
- •: LDL<100mg/dl, 150mg/dl=TG=400mg/dl
排除标准
- •1. Patients with acute artery disease within 3 months
- •2. Patients with congestive heart failure(NYHA class III~IV) or
- •uncontrolled arrhythmia within 6 months
- •3. Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
- •4. TSH>1.5X ULN
- •5. Patients with myopathy, rhabdomyolysis or CK>2X ULN
- •6. Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallery
- •or phototoxicity during fibrate and/or ketoprofen treatment
- •7. Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN
- •8. History of drug or alcohol abuse wtihin 6months
- •9. History of GI tract surgery or disability to drug absorption
- •10. Women with pregnant, breast-feeding
- •11. Patients with gallbladder disease
- •12. Patients with biliary cirrhosis
- •13. Patients with pancreatitis(acute pancreatitis is exlcuded due to
- •severe hypertriglyceridemia)
- •14. Patients treated with any investigational drugs within 4 weeks at
- •the time consents are obtained
- •15. History of malignant tumor including leukemia, lymphoma within 5
- •16. Patients must be treated with medications prohibited for concomitant
- •use during study period
- •17. Not eligible to participate for the study at the discretion of
- •investigator
研究者
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