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Completed

NCT Number: NCT00815659

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research site, Ankara, Besevler, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

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

Other names: CRESTOR

Primary outcomes

  1. Basal HDL-cholesterol Level

    Time frame: Baseline

    HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  2. HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  3. Basal LDL-cholesterol Level

    Time frame: Baseline

    LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  4. LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  5. Basal Total Cholesterol Level

    Time frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

    Baseline

  6. Total Cholesterol Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  7. Basal Triglyceride Level

    Time frame: Baseline

    Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  8. Triglyceride Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  9. 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)

    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

  10. 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)

    Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment

  11. 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)

    Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment

Secondary outcomes

  1. Basal Interleukin 1 (IL-1) Level

    Time frame: Baseline

    IL-1 levels before (Visit 2-enrollment)

  2. Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  3. Basal Interleukin 6 (IL-6) Level

    Time frame: Baseline

    IL-6 levels before (Visit 2-enrollment)

  4. Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  5. Basal Interleukin 8 (IL-8) Level

    Time frame: Baseline

    IL-8 levels before (Visit 2-enrollment)

  6. Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  7. Basal Interleukin 10 (IL-10) Level

    Time frame: Baseline

    IL-10 levels before (Visit 2-enrollment)

  8. Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  9. Basal Tumor Necrosis Factor (TNF) Level

    Time frame: Baseline

    TNF levels before (Visit 2-enrollment)

  10. Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  11. Basal High Sensitivity C-reactive Protein (Hs-CRP) Level

    Time frame: Baseline

    hs-CRP levels before (Visit 2-enrollment)

  12. High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  13. Basal LDL-3 Level

    Time frame: Baseline

    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

  14. LDL-3 Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  15. Basal LDL-4 Level

    Time frame: Baseline

    LDL-4 levels before (Visit 2-enrollment)

  16. LDL-4 Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  17. Basal LDL-5 Level

    Time frame: Baseline

    LDL-5 levels before (Visit 2-enrollment)

  18. LDL-5 Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  19. Basal LDL-6 Level

    Time frame: Baseline

    LDL-6 levels before (Visit 2-enrollment)

  20. LDL-6 Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  21. Basal LDL-7 Level

    Time frame: Baseline

    LDL-7 levels before (Visit 2-enrollment)

  22. LDL-7 Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  23. Basal Large HDL Subfraction Level

    Time frame: Baseline

    Large HDL subfraction levels before (Visit 2-enrollment)

  24. Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  25. Basal Intermediate HDL Subfraction Level

    Time frame: Baseline

    Intermediate HDL subfraction levels before (Visit 2-enrollment)

  26. Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  27. Basal Small HDL Subfraction Level

    Time frame: Baseline

    Small HDL subfraction levels before (Visit 2-enrollment)

  28. Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment

    Time frame: 3 months (from enrollment to last visit)

    Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  29. Number of Patients With Adverse Events

    Time frame: 3 months (from enrollment to last visit)

    Number of patients with any adverse events in 3 months of rosuvastatin treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

Acronym: EFFORT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 30, 2008
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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