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

Pin Siang Medical Biotechnology

Status: Unknown

Conditions: Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: Crestor®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982461

PSMB102ROS10-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Rosuvastatin

Experimental group

Description:

One Rosuvastatin tablet 10mg taken once daily.

Treatment:

Drug: Rosuvastatin

Crestor®

Active Comparator group

Description:

One Crestor® tablet 10mg taken once daily.

Treatment:

Drug: Crestor®