Trial Outcomes & Findings for Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia (NCT NCT00683618)
NCT ID: NCT00683618
Last Updated: 2012-03-21
Results Overview
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
COMPLETED
PHASE3
934 participants
baseline, 6 weeks
2012-03-21
Participant Flow
In total 934 patients were enrolled to the study, the study was conducted at 13 investigational sites in China. The first patient was enrolled on 27 May 2008, the last patient was completed on 16 Jul 2009.
There is a dietary lead in period before randomization. 934 patients started the dietary lead in period. 436 patients completed this period. The baseline measurement is based on the ITT population. Patients included in ITT population in each arm is : Rosuvastatin 5mg 136, Rosuvastatin 10mg 139 and Atorvastatin 10mg 139.
Participant milestones
| Measure |
Rosuvastatin 5mg
Taken orally once daily
|
Rosuvastatin 10mg
Taken orally once daily
|
Atorvastatin 10mg
Taken orally once daily
|
|---|---|---|---|
|
Randomised Treatment Period
STARTED
|
145
|
145
|
146
|
|
Randomised Treatment Period
COMPLETED
|
139
|
143
|
140
|
|
Randomised Treatment Period
NOT COMPLETED
|
6
|
2
|
6
|
|
Extension Treatment Period
STARTED
|
36
|
23
|
0
|
|
Extension Treatment Period
COMPLETED
|
33
|
23
|
0
|
|
Extension Treatment Period
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rosuvastatin 5mg
Taken orally once daily
|
Rosuvastatin 10mg
Taken orally once daily
|
Atorvastatin 10mg
Taken orally once daily
|
|---|---|---|---|
|
Randomised Treatment Period
Withdrawal by Subject
|
4
|
1
|
2
|
|
Randomised Treatment Period
Protocol Violation
|
0
|
1
|
0
|
|
Randomised Treatment Period
Adverse Event
|
2
|
0
|
2
|
|
Randomised Treatment Period
Reason not provided
|
0
|
0
|
2
|
|
Extension Treatment Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Extension Treatment Period
Adverse Event
|
1
|
0
|
0
|
|
Extension Treatment Period
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Rosuvastatin 5mg
n=136 Participants
Taken orally once daily
|
Rosuvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
60.4 Years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 10.57 • n=7 Participants
|
58.4 Years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 9.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
136 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
414 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Nativ Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Low density lipoprotein cholesterol (LDL-C level)
|
4.242 mmol/L
STANDARD_DEVIATION 0.6769 • n=5 Participants
|
4.131 mmol/L
STANDARD_DEVIATION 0.6818 • n=7 Participants
|
4.213 mmol/L
STANDARD_DEVIATION 0.6617 • n=5 Participants
|
4.186 mmol/L
STANDARD_DEVIATION 0.6717 • n=4 Participants
|
|
triglyceride (TG) level
|
1.921 mmol/L
STANDARD_DEVIATION 0.7825 • n=5 Participants
|
2.042 mmol/L
STANDARD_DEVIATION 0.9164 • n=7 Participants
|
2.061 mmol/L
STANDARD_DEVIATION 0.8971 • n=5 Participants
|
1.991 mmol/L
STANDARD_DEVIATION 0.8494 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeksAnalyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=136 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
|
-41.70 percent change
Standard Error 2.62 • Interval 2.62 to
|
-38.67 percent change
Standard Error 2.64 • Interval 2.64 to
|
—
|
PRIMARY outcome
Timeframe: baseline, 6 weeksAnalyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg
|
-46.28 Percent change
Standard Error 2.62 • Interval 2.62 to
|
-38.67 Percent change
Standard Error 2.64 • Interval 2.64 to
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=137 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=135 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
|
5.63 percent change
Standard Error 2.29 • Interval 2.29 to
|
6.82 percent change
Standard Error 2.29 • Interval 2.29 to
|
3.64 percent change
Standard Error 2.31 • Interval 2.31 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=135 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
|
-29.62 percent change
Standard Error 1.92 • Interval 1.92 to
|
-33.14 percent change
Standard Error 1.91 • Interval 1.91 to
|
-28.06 percent change
Standard Error 1.93 • Interval 1.93 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=135 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Triglycerides (TG) at Week 6
|
-20.09 Percent change
Standard Error 4.72 • Interval 4.72 to
|
-22.05 Percent change
Standard Error 4.69 • Interval 4.69 to
|
-20.67 Percent change
Standard Error 4.73 • Interval 4.73 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=137 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=134 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
|
-38.60 percent change
Standard Error 3.57 • Interval 3.57 to
|
-46.08 percent change
Standard Error 3.57 • Interval 3.57 to
|
-38.50 percent change
Standard Error 3.60 • Interval 3.6 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
|
-36.55 percent change
Standard Error 2.40 • Interval 2.4 to
|
-41.21 percent change
Standard Error 2.40 • Interval 2.4 to
|
-34.67 percent change
Standard Error 2.41 • Interval 2.41 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6
|
3.67 percent change
Standard Error 1.99 • Interval 1.99 to
|
4.25 percent change
Standard Error 1.98 • Interval 1.98 to
|
1.79 percent change
Standard Error 2.00 • Interval 2.0 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=137 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=134 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6
|
-32.95 percent change
Standard Error 2.96 • Interval 2.96 to
|
-38.04 percent change
Standard Error 2.96 • Interval 2.96 to
|
-31.92 percent change
Standard Error 2.99 • Interval 2.99 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=137 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=134 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6
|
-44.07 percent change
Standard Error 3.17 • Interval 3.17 to
|
-50.27 percent change
Standard Error 3.16 • Interval 3.16 to
|
-41.04 percent change
Standard Error 3.19 • Interval 3.19 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=137 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=134 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6
|
-41.79 percent change
Standard Error 11.54 • Interval 11.54 to
|
-56.63 percent change
Standard Error 11.52 • Interval 11.52 to
|
-48.33 percent change
Standard Error 11.64 • Interval 11.64 to
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Outcome measures
| Measure |
Rosuvastatin 5mg
n=134 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6
|
-37.62 percent change
Standard Error 3.15 • Interval 3.15 to
|
-41.87 percent change
Standard Error 3.14 • Interval 3.14 to
|
-35.15 percent change
Standard Error 3.16 • Interval 3.16 to
|
SECONDARY outcome
Timeframe: week 6Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Outcome measures
| Measure |
Rosuvastatin 5mg
n=136 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6
|
61.0 percentage of patients
|
79.1 percentage of patients
|
58.3 percentage of patients
|
SECONDARY outcome
Timeframe: week 6Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL); non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL),non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Outcome measures
| Measure |
Rosuvastatin 5mg
n=136 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=139 Participants
Taken orally once daily
|
|---|---|---|---|
|
6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6
|
66.9 percentage of patients
|
78.4 percentage of patients
|
60.4 percentage of patients
|
SECONDARY outcome
Timeframe: from week 6 to week 12Population: Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator's discretion.
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Outcome measures
| Measure |
Rosuvastatin 5mg
n=34 Participants
Taken orally once daily
|
Atorvastatin 10mg
n=21 Participants
Taken orally once daily
|
Atorvastatin 10mg
Taken orally once daily
|
|---|---|---|---|
|
Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration
|
41.2 percentage of patients
|
47.6 percentage of patients
|
—
|
Adverse Events
Rosuvastatin 5mg
Rosuvastatin 10mg
Atorvastatin 10mg
Serious adverse events
| Measure |
Rosuvastatin 5mg
n=145 participants at risk
Taken orally once daily
|
Rosuvastatin 10mg
n=145 participants at risk
Taken orally once daily
|
Atorvastatin 10mg
n=146 participants at risk
Taken orally once daily
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.69%
1/145
|
0.00%
0/145
|
0.00%
0/146
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/145
|
0.00%
0/145
|
0.68%
1/146
|
Other adverse events
| Measure |
Rosuvastatin 5mg
n=145 participants at risk
Taken orally once daily
|
Rosuvastatin 10mg
n=145 participants at risk
Taken orally once daily
|
Atorvastatin 10mg
n=146 participants at risk
Taken orally once daily
|
|---|---|---|---|
|
Investigations
Alanine Aminotransferase
|
1.4%
2/145
|
0.00%
0/145
|
0.00%
0/146
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.4%
2/145
|
2.1%
3/145
|
0.00%
0/146
|
|
Renal and urinary disorders
Myalgia
|
0.69%
1/145
|
0.00%
0/145
|
0.00%
0/146
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place