Compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Study identifier:D356FC00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, double-blind trial to compare the efficacy of rosuvastatin 5 and 10 mg to atorvastatin 10 mg in the treatment of high risk patients with hypercholesterolemia followed by an open label treatment period with rosuvastatin up-titrated to the maximum dose of 20 mg for those patients who do not achieve goal

Medical condition

Hypercholesterolemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin, Atorvastatin

Sex

All

Actual Enrollment

934

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 May 2008

Primary Completion Date: 01 Jul 2009

Study Completion Date: 01 Jul 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Beijing, China

Location

Research Site

Shanghai, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Tianjin, China

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin 5mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Experimental: 2 Rosuvastatin 10mg qd	Drug: Rosuvastatin Capsule/Tablet, oral, qd, 6 or 12 weeks Other Name: Crestor
Active Comparator: 3 Atorvastatin 10mg qd	Drug: Atorvastatin Capsule/Tablet, 10mg, oral, qd, 6 weeks Other Name: Lipitor

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Participant Flow for 2 periods

Period 1: Randomised treatment period

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
STARTED	145	145	146
COMPLETED	139	143	140
NOT COMPLETED	6	2	6
Withdrawal by Subject	4	1	2
Protocol Violation	0	1	0
Adverse Event	2	0	2
Reason not provided	0	0	2

Period 2: Extension treatment period

	Rosuvastatin 5mg	Rosuvastatin 10mg
STARTED	36	23
COMPLETED	33	23
NOT COMPLETED	3	0
Withdrawal by Subject	1	0
Adverse Event	1	0
Protocol Violation	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Baseline Measures

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg	Total
Number of Participants [units: Participants]	136	139	139	414
Age Continuous [units: Years] Mean ± Standard Deviation	60.4 ± 8.51	59.7 ± 10.57	58.4 ± 9.29	59.5 ± 9.51
Gender, Male/Female [units: Participants]
Female	84	85	77	246
Male	52	54	62	168
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	0	0	0	0
Asian	136	139	139	414
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Nativ Hawaiian or other Pacific Islander	0	0	0	0
Low density lipoprotein cholesterol (LDL-C level) [units: mmol/L] Mean ± Standard Deviation	4.242 ± 0.6769	4.131 ± 0.6818	4.213 ± 0.6617	4.186 ± 0.6717
triglyceride (TG) level [units: mmol/L] Mean ± Standard Deviation	1.921 ± 0.7825	2.042 ± 0.9164	2.061 ± 0.8971	1.991 ± 0.8494

Outcome Measures

1. Primary Outcome Measure: Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 5mg with atorvastatin 10mg [ Time Frame: baseline, 6 weeks ]

Measure Type	Primary
Measure Name	Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 5mg with atorvastatin 10mg
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	136	139
Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 5mg with atorvastatin 10mg [units: percent change] Least Squares Mean (Standard Error)	-41.70 (2.62)	-38.67 (2.64)

No statistical analysis provided for Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 5mg with atorvastatin 10mg

2. Primary Outcome Measure: Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 10mg with atorvastatin 10mg [ Time Frame: baseline, 6 weeks ]

Measure Type	Primary
Measure Name	Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 10mg with atorvastatin 10mg
Measure Description	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 0.025 on ITT population.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	139	139
Percentage change from baseline in Low density lipoprotein cholesterol (LDL-C) concentration after 6 weeks of treatment comparing rosuvastatin 10mg with atorvastatin 10mg [units: Percent change] Least Squares Mean (Standard Error)	-46.28 (2.62)	-38.67 (2.64)

3. Secondary Outcome Measure: Percentage change from baseline in High Density Lipoprotein-Cholesterol (HDL-C) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in High Density Lipoprotein-Cholesterol (HDL-C) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	137	135
Percentage change from baseline in High Density Lipoprotein-Cholesterol (HDL-C) at week 6 [units: percent change] Least Squares Mean (Standard Error)	5.63 (2.29)	6.82 (2.29)	3.64 (2.31)

No statistical analysis provided for Percentage change from baseline in High Density Lipoprotein-Cholesterol (HDL-C) at week 6

4. Secondary Outcome Measure: Percentage change from baseline in total cholesterol (TC ) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in total cholesterol (TC ) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	135	139	139
Percentage change from baseline in total cholesterol (TC ) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-29.62 (1.92)	-33.14 (1.91)	-28.06 (1.93)

No statistical analysis provided for Percentage change from baseline in total cholesterol (TC ) at week 6

5. Secondary Outcome Measure: Percentage change from baseline in triglycerides (TG) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in triglycerides (TG) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	135	139	139
Percentage change from baseline in triglycerides (TG) at week 6 [units: Percent change] Least Squares Mean (Standard Error)	-20.09 (4.72)	-22.05 (4.69)	-20.67 (4.73)

No statistical analysis provided for Percentage change from baseline in triglycerides (TG) at week 6

6. Secondary Outcome Measure: Percentage change from baseline in non High Density Lipoprotein-Cholesterol (nonHDL-C) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in non High Density Lipoprotein-Cholesterol (nonHDL-C) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	137	134
Percentage change from baseline in non High Density Lipoprotein-Cholesterol (nonHDL-C) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-38.60 (3.57)	-46.08 (3.57)	-38.50 (3.60)

No statistical analysis provided for Percentage change from baseline in non High Density Lipoprotein-Cholesterol (nonHDL-C) at week 6

7. Secondary Outcome Measure: Percentage change from baseline in Apolipoprotein B (ApoB) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in Apolipoprotein B (ApoB) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	139	139
Percentage change from baseline in Apolipoprotein B (ApoB) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-36.55 (2.40)	-41.21 (2.40)	-34.67 (2.41)

No statistical analysis provided for Percentage change from baseline in Apolipoprotein B (ApoB) at week 6

8. Secondary Outcome Measure: Percentage change from baseline in Apolipoprotein A-I (ApoA-I) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in Apolipoprotein A-I (ApoA-I) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	139	139
Percentage change from baseline in Apolipoprotein A-I (ApoA-I) at week 6 [units: percent change] Least Squares Mean (Standard Error)	3.67 (1.99)	4.25 (1.98)	1.79 (2.00)

No statistical analysis provided for Percentage change from baseline in Apolipoprotein A-I (ApoA-I) at week 6

9. Secondary Outcome Measure: Percentage change from baseline in total cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in total cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	137	134
Percentage change from baseline in total cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-32.95 (2.96)	-38.04 (2.96)	-31.92 (2.99)

No statistical analysis provided for Percentage change from baseline in total cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at week 6

10. Secondary Outcome Measure: Percentage change from baseline in Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	137	134
Percentage change from baseline in Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-44.07 (3.17)	-50.27 (3.16)	-41.04 (3.19)

No statistical analysis provided for Percentage change from baseline in Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) at week 6

11. Secondary Outcome Measure: Percentage change from baseline in non High Density lipoprotein cholesterol/High Density lipoprotein cholesterol (nonHDL-C/HDL-C) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in non High Density lipoprotein cholesterol/High Density lipoprotein cholesterol (nonHDL-C/HDL-C) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	137	134
Percentage change from baseline in non High Density lipoprotein cholesterol/High Density lipoprotein cholesterol (nonHDL-C/HDL-C) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-41.79 (11.54)	-56.63 (11.52)	-48.33 (11.64)

No statistical analysis provided for Percentage change from baseline in non High Density lipoprotein cholesterol/High Density lipoprotein cholesterol (nonHDL-C/HDL-C) at week 6

12. Secondary Outcome Measure: Percentage change from baseline in apolipoprotein B/apolipoprotein A I (ApoB/ApoA-I) at week 6 [ Time Frame: baseline, 6 weeks ]

Measure Type	Secondary
Measure Name	Percentage change from baseline in apolipoprotein B/apolipoprotein A I (ApoB/ApoA-I) at week 6
Measure Description	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.
Time Frame	baseline, 6 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	134	139	139
Percentage change from baseline in apolipoprotein B/apolipoprotein A I (ApoB/ApoA-I) at week 6 [units: percent change] Least Squares Mean (Standard Error)	-37.62 (3.15)	-41.87 (3.14)	-35.15 (3.16)

No statistical analysis provided for Percentage change from baseline in apolipoprotein B/apolipoprotein A I (ApoB/ApoA-I) at week 6

13. Secondary Outcome Measure: Percentage of patients achieved ATP III guideline (2001) Low density lipoprotein cholesterol (LDL-C) goal at week 6 [ Time Frame: week 6 ]

Measure Type	Secondary
Measure Name	Percentage of patients achieved ATP III guideline (2001) Low density lipoprotein cholesterol (LDL-C) goal at week 6
Measure Description	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)
Time Frame	week 6
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	136	139	139
Percentage of patients achieved ATP III guideline (2001) Low density lipoprotein cholesterol (LDL-C) goal at week 6 [units: percentage of patients]	61.0	79.1	58.3

No statistical analysis provided for Percentage of patients achieved ATP III guideline (2001) Low density lipoprotein cholesterol (LDL-C) goal at week 6

14. Secondary Outcome Measure: 6 weeksPercentage of patients achieved ATP III guideline (2001) non High Density Lipoprotein-Cholesterol (nonHDL-C) goal at week 6 [ Time Frame: week 6 ]

Measure Type	Secondary
Measure Name	6 weeksPercentage of patients achieved ATP III guideline (2001) non High Density Lipoprotein-Cholesterol (nonHDL-C) goal at week 6
Measure Description	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)
Time Frame	week 6
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	136	139	139
6 weeksPercentage of patients achieved ATP III guideline (2001) non High Density Lipoprotein-Cholesterol (nonHDL-C) goal at week 6 [units: percentage of patients]	66.9	78.4	60.4

No statistical analysis provided for 6 weeksPercentage of patients achieved ATP III guideline (2001) non High Density Lipoprotein-Cholesterol (nonHDL-C) goal at week 6

15. Secondary Outcome Measure: 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 [ Time Frame: from week 6 to week 12 ]

Measure Type	Secondary
Measure Name	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
Measure Description	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)
Time Frame	from week 6 to week 12
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Measured Values

	Rosuvastatin 5mg	Rosuvastatin 10mg	Atorvastatin 10mg
Number of Participants Analyzed [units:participants]	34	21	0
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 [units: percentage of patients]	41.2	47.6

No statistical analysis provided for 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

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Serious Adverse Events

Rosuvastatin 5mg

Rosuvastatin 10mg

Atorvastatin 10mg

Total, serious adverse events

# participants affected / at risk

1/145 (0.69%)

0/145 (0.00%)

1/146 (0.68%)

Injury, poisoning and procedural complications

Foot Fracture¹,^†

# participants affected / at risk

1/145 (0.69%)

0/145 (0.00%)

0/146 (0.00%)

Injury, poisoning and procedural complications

Humerus Fracture¹,^†

# participants affected / at risk

0/145 (0.00%)

1/146 (0.68%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Rosuvastatin 5mg	Taken orally once daily
Rosuvastatin 10mg	Taken orally once daily
Atorvastatin 10mg	Taken orally once daily

Other Adverse Events

Rosuvastatin 5mg

Rosuvastatin 10mg

Atorvastatin 10mg

Total, other (not including serious) adverse events

# participants affected / at risk

5/145 (3.45%)

3/145 (2.07%)

0/146 (0.00%)

Investigations

Alanine Aminotransferase¹,^†

# participants affected / at risk

2/145 (1.38%)

0/145 (0.00%)

0/146 (0.00%)

Investigations

Blood Creatine Phosphokinase Increased²,^†

# participants affected / at risk

2/145 (1.38%)

3/145 (2.07%)

0/146 (0.00%)

Renal and urinary disorders

Myalgia²,^†

# participants affected / at risk

1/145 (0.69%)

0/145 (0.00%)

0/146 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary, MedDRA (10.0)
3	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=328&filename=CSR-D356FC00007.pdf
Download
CSR-D356FC00007.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Marco Avila

86-21-52564555

marco.avila@astrazeneca.com

Investigators

Principal Investigator

Marie Eckerd

AZ Pharmaceuticals - US

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=328&filename=CSR-D356FC00007.pdf

CSR-D356FC00007.pdf

Trial Results Summaries