A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks. [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
- The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
One Rosuvastatin tablet 10mg taken once daily.
Other Name: Roty
Active Comparator: Crestor®
One Crestor® tablet 10mg taken once daily.
|Contact: Lu-Hsin Lu, M.S.||886-2-26270255 ext email@example.com|
|Tri-Service General Hospital||Recruiting|
|Taipei, Taiwan, 11490|
|Contact 886-2-87923311 ext 10552 firstname.lastname@example.org|
|Principal Investigator:||Yi-Jen Hung, M.D.||Tri-Service General Hospital|