Text Size

Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00815659
First received: December 29, 2008
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Intervention: Drug: rosuvastatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks

Participant Flow:   Overall Study
    Crestor  
STARTED     97  
COMPLETED     74  
NOT COMPLETED     23  
Adverse Event                 9  
Withdrawal by Subject                 9  
Lost to Follow-up                 4  
Protocol Violation                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks

Baseline Measures
    Crestor  
Number of Participants  
[units: participants]
 		  97  
Age  
[units: Years]
Mean ± Standard Deviation 		  50.9  ± 9.5  
Gender  
[units: Participants]
 		 
Female     57  
Male     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Basal HDL-cholesterol Level   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 2

3.  Primary:   Basal LDL-cholesterol Level   [ Time Frame: Baseline ]
  Show Outcome Measure 3

4.  Primary:   LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 4

5.  Primary:   Basal Total Cholesterol Level   [ Time Frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) ]
  Show Outcome Measure 5

6.  Primary:   Total Cholesterol Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 6

7.  Primary:   Basal Triglyceride Level   [ Time Frame: Baseline ]
  Show Outcome Measure 7

8.  Primary:   Triglyceride Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 8

9.  Primary:   Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 9

10.  Primary:   Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Hide Outcome Measure 10

Measure Type Primary
Measure Title Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Measure Description Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Time Frame 3 months (from enrollment to last visit)  
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.
HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits

Reporting Groups
  Description
Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks

Measured Values
    Crestor  
Number of Participants Analyzed  
[units: participants]
 		  66  
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment  
[units: Participants]
 		  39  

No statistical analysis provided for Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment



11.  Primary:   Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 11

12.  Secondary:   Basal Interleukin 1 (IL-1) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 12

13.  Secondary:   Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 13

14.  Secondary:   Basal Interleukin 6 (IL-6) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 14

15.  Secondary:   Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 15

16.  Secondary:   Basal Interleukin 8 (IL-8) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 16

17.  Secondary:   Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 17

18.  Secondary:   Basal Interleukin 10 (IL-10) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 18

19.  Secondary:   Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 19

20.  Secondary:   Basal Tumor Necrosis Factor (TNF) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 20

21.  Secondary:   Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 21

22.  Secondary:   Basal High Sensitivity C-reactive Protein (Hs-CRP) Level   [ Time Frame: Baseline ]
  Show Outcome Measure 22

23.  Secondary:   High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 23

24.  Secondary:   Basal LDL-3 Level   [ Time Frame: Baseline ]
  Show Outcome Measure 24

25.  Secondary:   LDL-3 Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 25

26.  Secondary:   Basal LDL-4 Level   [ Time Frame: Baseline ]
  Show Outcome Measure 26

27.  Secondary:   LDL-4 Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 27

28.  Secondary:   Basal LDL-5 Level   [ Time Frame: Baseline ]
  Show Outcome Measure 28

29.  Secondary:   LDL-5 Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 29

30.  Secondary:   Basal LDL-6 Level   [ Time Frame: Baseline ]
  Show Outcome Measure 30

31.  Secondary:   LDL-6 Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 31

32.  Secondary:   Basal LDL-7 Level   [ Time Frame: Baseline ]
  Show Outcome Measure 32

33.  Secondary:   LDL-7 Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 33

34.  Secondary:   Basal Large HDL Subfraction Level   [ Time Frame: Baseline ]
  Show Outcome Measure 34

35.  Secondary:   Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 35

36.  Secondary:   Basal Intermediate HDL Subfraction Level   [ Time Frame: Baseline ]
  Show Outcome Measure 36

37.  Secondary:   Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 37

38.  Secondary:   Basal Small HDL Subfraction Level   [ Time Frame: Baseline ]
  Show Outcome Measure 38

39.  Secondary:   Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 39

40.  Secondary:   Number of Patients With Adverse Events   [ Time Frame: 3 months (from enrollment to last visit) ]
  Show Outcome Measure 40


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT00815659     History of Changes
Other Study ID Numbers: D3560L00079
Study First Received: December 29, 2008
Results First Received: March 24, 2011
Last Updated: August 29, 2011
Health Authority: Turkey: Ministry of Health