A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
- Registration Number
- NCT01982461
- Lead Sponsor
- Pin Siang Medical Biotechnology Co., Ltd.
- Brief Summary
The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Male or female aged 20 to 85;
- LDL - C between 130 mg/dL and 250 mg/dL;
- TG < 400 mg/dL;
- Who without use of any statin within 2 week prior to the trial;
- Informed consent given.
Exclusion Criteria
- Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy;
- Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN);
- Treatment with Cyclosporin or any disallowed drug;
- Patients with unstable angina pectoris;
- Pregnant, lactating women;
- Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Crestor® Crestor® One Crestor® tablet 10mg taken once daily. Rosuvastatin Rosuvastatin One Rosuvastatin tablet 10mg taken once daily.
- Primary Outcome Measures
Name Time Method The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks. baseline to week 12
- Secondary Outcome Measures
Name Time Method The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. baseline to week 12
Trial Locations
- Locations (1)
Tri-Service General Hospital
🇨🇳Taipei, Taiwan