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
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Drug: rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Basal HDL-cholesterol Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  • HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-cholesterol Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  • LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Total Cholesterol Level [ Time Frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) ] [ Designated as safety issue: No ]
    Baseline

  • Total Cholesterol Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Triglyceride Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)

  • Triglyceride Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IL-1 levels before (Visit 2-enrollment)

  • Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Interleukin 6 (IL-6) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IL-6 levels before (Visit 2-enrollment)

  • Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Interleukin 8 (IL-8) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IL-8 levels before (Visit 2-enrollment)

  • Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Interleukin 10 (IL-10) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IL-10 levels before (Visit 2-enrollment)

  • Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Tumor Necrosis Factor (TNF) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    TNF levels before (Visit 2-enrollment)

  • Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal High Sensitivity C-reactive Protein (Hs-CRP) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    hs-CRP levels before (Visit 2-enrollment)

  • High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-3 Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-4 Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    LDL-4 levels before (Visit 2-enrollment)

  • LDL-4 Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-5 Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    LDL-5 levels before (Visit 2-enrollment)

  • LDL-5 Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-6 Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    LDL-6 levels before (Visit 2-enrollment)

  • LDL-6 Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal LDL-7 Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    LDL-7 levels before (Visit 2-enrollment)

  • LDL-7 Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Large HDL Subfraction Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Large HDL subfraction levels before (Visit 2-enrollment)

  • Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Intermediate HDL Subfraction Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Intermediate HDL subfraction levels before (Visit 2-enrollment)

  • Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Basal Small HDL Subfraction Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Small HDL subfraction levels before (Visit 2-enrollment)

  • Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: No ]
    Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

  • Number of Patients With Adverse Events [ Time Frame: 3 months (from enrollment to last visit) ] [ Designated as safety issue: Yes ]
    Number of patients with any adverse events in 3 months of rosuvastatin treatment


Enrollment: 97
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Drug: rosuvastatin
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Other Name: CRESTOR

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815659

Locations
Turkey
Research site
Ankara, Besevler, Turkey
Research site
Kayseri, Erciyes, Turkey
Research site
Istanbul, Haseki, Turkey
Research site
Kocaeli, Umuttepe, Turkey
Research Site
Izmir, Turkey
Research Site
Trabzon, Turkey
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dilek Ural, MD, Prof Kocaeli University Faculty of Medicine Cardiology Dept
  More Information

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

Keywords provided by AstraZeneca:
plasma lipid profile
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014