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Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00683618
First received: May 21, 2008
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
Results First Received: July 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

  Participant Flow
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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     Atorvastatin 10mg  
STARTED     36     23     0  
COMPLETED     33     23     0  
NOT COMPLETED     3     0     0  
Withdrawal by Subject                 1                 0                 0  
Adverse Event                 1                 0                 0  
Protocol Violation                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Rosuvastatin 5mg Taken orally once daily
Rosuvastatin 10mg Taken orally once daily
Atorvastatin 10mg Taken orally once daily
Total Total of all reporting groups

Baseline Measures
    Rosuvastatin 5mg     Rosuvastatin 10mg     Atorvastatin 10mg     Total  
Number of Participants  
[units: participants]
 		  136     139     139     414  
Age  
[units: Years]
Mean ± Standard Deviation 		  60.4  ± 8.51     59.7  ± 10.57     58.4  ± 9.29     59.5  ± 9.51  
Gender  
[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
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Primary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6   [ Time Frame: baseline, 6 weeks ]
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4.  Secondary:   Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Percentage Change From Baseline in Triglycerides (TG) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title 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:   Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 9

10.  Secondary:   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 ]
  Show Outcome Measure 10

11.  Secondary:   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 ]
  Show Outcome Measure 11

12.  Secondary:   Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6   [ Time Frame: baseline, 6 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6   [ Time Frame: week 6 ]
  Show Outcome Measure 13

14.  Secondary:   6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6   [ Time Frame: week 6 ]
  Show Outcome Measure 14

15.  Secondary:   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 ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00683618     History of Changes
Other Study ID Numbers: D356FC00007
Study First Received: May 21, 2008
Results First Received: July 9, 2010
Last Updated: March 19, 2012
Health Authority: China: Ethics Committee
China: Food and Drug Administration