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

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01982461
• Other study ID #: PSMB102ROS10-01
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2013
• Last updated: November 6, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: Pin Siang Medical Biotechnology Co., Ltd.
• Contact: Lu-Hsin Lu, M.S.
• Phone: 886-2-26270255
• Email: flora[@]twtungda.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
10mg,once daily
• Crestor®
10mg,once daily

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pin Siang Medical Biotechnology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.		baseline to week 12	No
Secondary	The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.		baseline to week 12	No