Short term efficacy and safety of generic rosuvastatin (K-zuva) versus brand rosuvastatin (Crestor) for the treatment in patients with hypercholesterolemia
- Conditions
- HypercholesterlemiaHypercholesterlemia, Low Density Lipoprotein-Cholesterol, LDL-C
- Registration Number
- TCTR20221209001
- Lead Sponsor
- Health System Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 240
1. Age >/= 35 years
2. LDL-C level according to criteria
1. Uncontrolled DM within 3 mounts before screening visit or HbA1C >8%
2. Serum triglyceride >/= 500mg/dL
3. History of uncontrolled thyroid disease with in 1 year before screening
4. History of gastrointestinal disease
5. AST, ALT, alkaline phosphate, bilirubin any value more than 2 times of upper limit of normal for the reference laboratory
6. Serum creatinine more than 2 .0 mg/dL
7. Creatinine phosphokinase(CPK) more than 2-fold the upper limit of normal
8. Uncontrolled hypertension(DBP > 100 mmHg or SBP > 160 mmHg)
9. Unstable angina, Congestive heart failure or orther uncontrolled cardiac disease
10. Female who is pregnant or breast-feeding
11. History of substance abuse or have a mental illness that may affect protocol compliance
12. History of take dietary supplement products that have medical evidence for reduce lipid level
13. Drinking every day (Beer more than 12 ounce, Wine more than 6 ounce or Alcohol more than 2 ounce)
14. Any disorder, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
15. Participation in any clinical trial with in 30 days before screening
16. History of any medication taken that may interact with rosuvastatin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-C at 6 week after enrollment LDL-C level
- Secondary Outcome Measures
Name Time Method Total cholesterol at 6 week after enrollment Percentage of change of total cholesterol level,Triglycerides at 6 week after enrollment Percentage of change of triglyceride level,HDL-C at 6 week after enrollment Percentage of change of HDL-C level,Complication at 6 week after enrollment Percentage of subject who have complication from study drug