A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
|ClinicalTrials.gov Identifier: NCT01982461|
Recruitment Status : Unknown
Verified November 2013 by Pin Siang Medical Biotechnology Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 13, 2013
Last Update Posted : November 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: Rosuvastatin Drug: Crestor®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||January 2014|
One Rosuvastatin tablet 10mg taken once daily.
Other Name: Roty
Active Comparator: Crestor®
One Crestor® tablet 10mg taken once daily.
Other Name: Rosuvastatin
- 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 ]
- The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1. [ Time Frame: baseline to week 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982461
|Contact: Lu-Hsin Lu, M.S.||886-2-26270255 ext firstname.lastname@example.org|
|Tri-Service General Hospital||Recruiting|
|Taipei, Taiwan, 11490|
|Contact 886-2-87923311 ext 10552 email@example.com|
|Principal Investigator:||Yi-Jen Hung, M.D.||Tri-Service General Hospital|