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Short term efficacy and safety of generic rosuvastatin (K-zuva) versus brand rosuvastatin (Crestor) for the treatment in patients with hypercholesterolemia

Short term efficacy and safety of generic rosuvastatin (K-zuva) versus brand rosuvastatin (Crestor) for the treatment in patients with hypercholesterolemia

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221209001
Enrollment
240
Registered
2022-12-09
Start date
2020-03-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterlemia Hypercholesterlemia, Low Density Lipoprotein-Cholesterol, LDL-C

Interventions

Naive group 1. Crestor group : Crestor 10 mg/day, appointment at 2, 4 and 6 weeks 2. Kzuva group : Kzuva 10 mg/day, appointment at 2, 4 and 6 weeks,Failure statin dose 20 mg 1. Crestor group : Crestor
Naive,Failure statin dose 20 mg,Failure statin dose 20 mg,Failure statin dose 40 mg

Sponsors

Health System Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >/= 35 years 2. LDL-C level according to criteria

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
LDL-C at 6 week after enrollment LDL-C level

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSaranyou Suwanugsorn

Faculty of Medicine Prince of Songkla University

poohsupattra@gmail.com0898780710

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026