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

NCT00815659 | Completed Phase 4 Results

• 1 other identifier: D3560L00079
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 6

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.

Conditions

Metabolic Syndrome

Keywords

plasma lipid profile; metabolic syndrome

Outcome Measures

Primary Outcomes (11)

• Basal HDL-cholesterol Level

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

  Baseline

• HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment

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

  3 months (from enrollment to last visit)

• Basal LDL-cholesterol Level

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

  Baseline

• LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment

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

  3 months (from enrollment to last visit)

• Basal Total Cholesterol Level

  Baseline

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

• Total Cholesterol Level After 3 Months of Rosuvastatin Treatment

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

  3 months (from enrollment to last visit)

• Basal Triglyceride Level

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

  Baseline

• Triglyceride Level After 3 Months of Rosuvastatin Treatment

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

  3 months (from enrollment to last visit)

• 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

  3 months (from enrollment to last visit)

• 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

  3 months (from enrollment to last visit)

• 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

  3 months (from enrollment to last visit)

Secondary Outcomes (29)

• Basal Interleukin 1 (IL-1) Level

  Baseline

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

  3 months (from enrollment to last visit)

• Basal Interleukin 6 (IL-6) Level

  Baseline

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

  3 months (from enrollment to last visit)

• Basal Interleukin 8 (IL-8) Level

  Baseline

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

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

Drug: rosuvastatin

Interventions

rosuvastatin DRUG

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

Also known as: CRESTOR

Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research site

Ankara, Besevler, Turkey (Türkiye)

Location

Research site

Kayseri, Erciyes, Turkey (Türkiye)

Location

Research site

Istanbul, Haseki, Turkey (Türkiye)

Location

Research site

Kocaeli, Umuttepe, Turkey (Türkiye)

Location

Research Site

Izmir, Turkey (Türkiye)

Location

Research Site

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Dilek Ural, MD, Prof

  Kocaeli University Faculty of Medicine Cardiology Dept

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 31, 2011
• Results First Posted: July 4, 2011

Record last verified: 2011-08

Locations

TU (6)