Complex Dyslipidemia Clinical Trial
Official title:
Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
| Verified date | July 2015 |
| Source | Yooyoung Pharmaceutical Co.,Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | Observational |
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:
1. 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.
2. 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.
3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid
parameter variation when treating patients by altered drugs for 3±1 months,
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | June 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who has dyslipidemia of type 2 diabetes. 1. Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months. 2. Patients who have the result of lipid paraneter test (LDL-C =100mg/dL, TG =150mg/dL) at baseline. 3. Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline. 4. Patients' age were > 20 years and <75 year. Exclusion Criteria: 1. Patients who ahs HbA1c=9% 2. 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 3. Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis. 4. Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period 5. Renal abnormality 6. Alcoholism or Alcohol abuse 7. Patients treated by Steroids. 8. Pregnant or lactating woman 9. Patients who are judged as not suitable for this study by Investigator. |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | The Catholic University of Korea(Bucheon St. Mary's Hospital) | Bucheon |
| Lead Sponsor | Collaborator |
|---|---|
| Yooyoung Pharmaceutical Co.,Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Setting the sub-group by the result of lipid parameter | Decreasing HDL-C: HDL-C=40mg/dL(Man), =50mg/dL(Woman) Non-decreasing HDL-C: HDL-C=40mg/dL(Man), >50mg/dL(Woman) | Basis on the Base-line | No |
| Primary | Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug. | Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG | Over 3±1 months | No |
| Secondary | The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug. | Increasing LDL-C + TG Decreasing HDL-C + Increasing TG | Over 3±1 months | No |
| Secondary | Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug. | Increasing LDL-C + TGDecreasing HDL-C + Increasing TG | Over 3±1 months | No |