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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring plasma lipid profile, metabolic syndrome

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
  • LDL-Cholesterol > 130mg/dl
  • HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
  • Triglycerides < 400 mg/dl

Exclusion Criteria:

  • With a concomitant coronary disease
  • Currently under statin therapy or previously treated with statins within the last 6 months

Sites / Locations

  • Research site
  • Research site
  • Research site
  • Research site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rosuvastatin

Arm Description

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Outcomes

Primary Outcome Measures

Basal HDL-cholesterol Level
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-cholesterol Level
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Total Cholesterol Level
Baseline
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Triglyceride Level
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment

Secondary Outcome Measures

Basal Interleukin 1 (IL-1) Level
IL-1 levels before (Visit 2-enrollment)
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 6 (IL-6) Level
IL-6 levels before (Visit 2-enrollment)
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 8 (IL-8) Level
IL-8 levels before (Visit 2-enrollment)
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 10 (IL-10) Level
IL-10 levels before (Visit 2-enrollment)
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Tumor Necrosis Factor (TNF) Level
TNF levels before (Visit 2-enrollment)
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
hs-CRP levels before (Visit 2-enrollment)
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-3 Level
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
LDL-3 Level After 3 Months of Rosuvastatin Treatment
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-4 Level
LDL-4 levels before (Visit 2-enrollment)
LDL-4 Level After 3 Months of Rosuvastatin Treatment
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-5 Level
LDL-5 levels before (Visit 2-enrollment)
LDL-5 Level After 3 Months of Rosuvastatin Treatment
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-6 Level
LDL-6 levels before (Visit 2-enrollment)
LDL-6 Level After 3 Months of Rosuvastatin Treatment
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-7 Level
LDL-7 levels before (Visit 2-enrollment)
LDL-7 Level After 3 Months of Rosuvastatin Treatment
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Large HDL Subfraction Level
Large HDL subfraction levels before (Visit 2-enrollment)
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Intermediate HDL Subfraction Level
Intermediate HDL subfraction levels before (Visit 2-enrollment)
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Small HDL Subfraction Level
Small HDL subfraction levels before (Visit 2-enrollment)
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients With Adverse Events
Number of patients with any adverse events in 3 months of rosuvastatin treatment

Full Information

First Posted
December 29, 2008
Last Updated
August 29, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00815659
Brief Title
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Acronym
EFFORT
Official Title
Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
plasma lipid profile, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
CRESTOR
Intervention Description
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Primary Outcome Measure Information:
Title
Basal HDL-cholesterol Level
Description
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time Frame
Baseline
Title
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
Description
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-cholesterol Level
Description
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time Frame
Baseline
Title
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
Description
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Total Cholesterol Level
Description
Baseline
Time Frame
Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Title
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Description
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Triglyceride Level
Description
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time Frame
Baseline
Title
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Description
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Description
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL
Time Frame
3 months (from enrollment to last visit)
Title
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
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)
Title
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Description
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)
Secondary Outcome Measure Information:
Title
Basal Interleukin 1 (IL-1) Level
Description
IL-1 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
Description
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Interleukin 6 (IL-6) Level
Description
IL-6 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
Description
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Interleukin 8 (IL-8) Level
Description
IL-8 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
Description
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Interleukin 10 (IL-10) Level
Description
IL-10 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
Description
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Tumor Necrosis Factor (TNF) Level
Description
TNF levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
Description
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
Description
hs-CRP levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
Description
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-3 Level
Description
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
Time Frame
Baseline
Title
LDL-3 Level After 3 Months of Rosuvastatin Treatment
Description
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-4 Level
Description
LDL-4 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
LDL-4 Level After 3 Months of Rosuvastatin Treatment
Description
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-5 Level
Description
LDL-5 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
LDL-5 Level After 3 Months of Rosuvastatin Treatment
Description
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-6 Level
Description
LDL-6 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
LDL-6 Level After 3 Months of Rosuvastatin Treatment
Description
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal LDL-7 Level
Description
LDL-7 levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
LDL-7 Level After 3 Months of Rosuvastatin Treatment
Description
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Large HDL Subfraction Level
Description
Large HDL subfraction levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Description
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Intermediate HDL Subfraction Level
Description
Intermediate HDL subfraction levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Description
Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Basal Small HDL Subfraction Level
Description
Small HDL subfraction levels before (Visit 2-enrollment)
Time Frame
Baseline
Title
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Description
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time Frame
3 months (from enrollment to last visit)
Title
Number of Patients With Adverse Events
Description
Number of patients with any adverse events in 3 months of rosuvastatin treatment
Time Frame
3 months (from enrollment to last visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria) LDL-Cholesterol > 130mg/dl HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females Triglycerides < 400 mg/dl Exclusion Criteria: With a concomitant coronary disease Currently under statin therapy or previously treated with statins within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Ural, MD, Prof
Organizational Affiliation
Kocaeli University Faculty of Medicine Cardiology Dept
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research site
City
Ankara
State/Province
Besevler
Country
Turkey
Facility Name
Research site
City
Kayseri
State/Province
Erciyes
Country
Turkey
Facility Name
Research site
City
Istanbul
State/Province
Haseki
Country
Turkey
Facility Name
Research site
City
Kocaeli
State/Province
Umuttepe
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Trabzon
Country
Turkey

12. IPD Sharing Statement

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

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