ROMEO (Rosuvastatin in Metabolic syndrOme)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br> | Drug: Rosuvastatin<br>* 10mg<br>* Other names: Crestor;|
| Active Comparator: Atorvastatin<br> | Drug: Atorvastatin<br>* 10mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 | 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Reaching Their LDL-C Target Goal | 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). | Baseline and 6 weeks | 
| Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal | Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal. | Baseline and 6 weeks | 
| Percentage Change of Glucose Level | Using laboratory test, mean change of glucose level was investigated. | Baseline and 6 weeks | 
| Percentage Change of Insulin Resistance Using HOMA-R | HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5 | Baseline and 6 weeks | 
| Percentage Change of Insulin Resistance Using QUICKI | QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)]. | Baseline and 6 weeks | 
| Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) | Calculate the percentage reduction of LDL-C | Baseline and 6 weeks | 
| Percentage Change of Total Cholesterol (TC) | Calculate the percentage change of total cholesterol level | Baseline and 6 weeks | 
| Percentage Change of High-Density Lipoprotein-C (HDL-C) | Calculate the percentage change of HDL-C level | Baseline and 6 weeks | 
| Percentage Change of Triglycerides (TG) | Calculate the percentage change of Triglycerides. | Baseline and 6 weeks | 
| Percentage Change of Apolipoprotein A1 (ApoA1) | Calculate the percentage change of Apolipoprotein A1 | Baseline and 6 weeks | 
| Percentage Change of Apolipoprotein B (ApoB) | Calculate the percentage change of apolipoprotein B | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosuvastatin, lipoprotein, metabolic syndrome