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临床试验/NCT02382159
NCT02382159已完成不适用

Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.

Yooyoung Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.

研究概览

简要总结

  1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014.

  2. Study objective:

  3. The objective of this study is to Identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.

  4. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months, identifying the reason why changing method of drug dosage and pharmacotherapy.

  5. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who has dyslipidemia of type 2 diabetes.
  • Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months.
  • Patients who have the result of lipid paraneter test (LDL-C ≥100mg/dL, TG ≥150mg/dL) at baseline.
  • Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline.
  • Patients' age were > 20 years and <75 year.

排除标准

  • Patients who ahs HbA1c≥9%
  • Patients who have no the result of lipid parameter test at baseline and at baseline and after lipid-lowering drug for at least 3 months
  • Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis.
  • Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period
  • Renal abnormality
  • Alcoholism or Alcohol abuse
  • Patients treated by Steroids.
  • Pregnant or lactating woman
  • Patients who are judged as not suitable for this study by Investigator.

结局指标

主要结局

Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.

时间窗: Over 3±1 months

Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG

次要结局

  • The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.(Over 3±1 months)
  • Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.(Over 3±1 months)

研究者

发起方
Yooyoung Pharmaceutical Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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