A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pin Siang Medical Biotechnology Co., Ltd.
• Treatments: Rosuvastatin Calcium

Criteria

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.