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ROMEO (Rosuvastatin in Metabolic syndrOme)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395486
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : June 16, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Drug: Rosuvastatin Drug: Atorvastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-week, Randomised, Open-label, Parallel Group, Multi-centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Metabolic Syndrome Subjects With Raised LDL-C
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rosuvastatin Drug: Rosuvastatin
10mg
Other Name: Crestor
Active Comparator: Atorvastatin Drug: Atorvastatin
10mg


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 [ Time Frame: Baseline and 6 weeks ]
    Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.


Secondary Outcome Measures :
  1. Percentage of Subjects Reaching Their LDL-C Target Goal [ Time Frame: Baseline and 6 weeks ]
    Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).

  2. Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal [ Time Frame: Baseline and 6 weeks ]
    Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.

  3. Percentage Change of Glucose Level [ Time Frame: Baseline and 6 weeks ]
    Using laboratory test, mean change of glucose level was investigated.

  4. Percentage Change of Insulin Resistance Using HOMA-R [ Time Frame: Baseline and 6 weeks ]
    HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5

  5. Percentage Change of Insulin Resistance Using QUICKI [ Time Frame: Baseline and 6 weeks ]
    QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].

  6. Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage reduction of LDL-C

  7. Percentage Change of Total Cholesterol (TC) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage change of total cholesterol level

  8. Percentage Change of High-Density Lipoprotein-C (HDL-C) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage change of HDL-C level

  9. Percentage Change of Triglycerides (TG) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage change of Triglycerides.

  10. Percentage Change of Apolipoprotein A1 (ApoA1) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage change of Apolipoprotein A1

  11. Percentage Change of Apolipoprotein B (ApoB) [ Time Frame: Baseline and 6 weeks ]
    Calculate the percentage change of apolipoprotein B


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of 3 or more of the following criteria;

    • Abdominal obesity (men >90cm women >80cm)
    • Triglycerides ≥ 150 mg/dL
    • HDL-C: men < 40 mg/dL, women < 50 mg/dL
    • BP ≥130/≥85 mmHg or anti-hypertensive treatment
    • Fasting blood glucose ≥100 mg dL or anti-diabetic treatment

  • Elevated LDL-C ;

    • ≥130 mg/dL to < 220 mg/dL in lipid lowering agent naive subjects
    • ≥100 mg/dL to < 200 mg/dL in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1.
  • Triglyceride < 500 mg/dL
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395486


Locations
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Korea, Republic of
Research Site
Pusan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: JoonWoo Bahn, MD AstraZeneca
More Information
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00395486    
Other Study ID Numbers: D3560L00061
ROMEO
First Posted: November 3, 2006    Key Record Dates
Results First Posted: June 16, 2011
Last Update Posted: July 11, 2011
Last Verified: June 2011
Keywords provided by AstraZeneca:
rosuvastatin
lipoprotein
metabolic syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
 Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors