This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
454
FDC of EZ10 mg/Ator 10mg
FDC of EZ10 mg/Ator 20mg
Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
Percent Change From Baseline in LDL-C at Week 12
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
Time frame: Baseline (Day 1) and Week 12
Percentage of Participants With An Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 17 weeks
Number of Participants Who Discontinued From Study Treatment
The number of participants who discontinued treatment over the 12-week treatment period was assessed.
Time frame: Up to approximately 15 weeks
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A single placebo tablet administered orally QD for 84 days
Two placebo tablets matching atorvastatin administered orally QD for 84 days
The First Affiliated Hospital of Baotou Medical College ( Site 0025)
Baotou, Anhui, China
Beijing Anzhen Hospital. Capital Medical University ( Site 0001)
Beijing, Anhui, China
Aero Space center hospital ( Site 0003)
Beijing, Beijing Municipality, China
Beijing Friendship Hospital ( Site 0005)
Beijing, Beijing Municipality, China
Chongqing General Hospital ( Site 0037)
Chongqing, Chongqing Municipality, China
Lanzhou University Second Hospital ( Site 0041)
Lanzhou, Gansu, China
Guangdong General Hospital ( Site 0006)
Guangzhou, Guangdong, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 0007)
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 0008)
Guangzhou, Guangdong, China
Daqing Oilfield General Hospital ( Site 0010)
Daqing, Heilongjiang, China
...and 20 more locations