ROMEO (Rosuvastatin in Metabolic syndrOme)

Phase 4

Completed

Conditions: Metabolic Syndrome X

Interventions: Drug: Rosuvastatin
Drug: Atorvastatin

Registration Number: NCT00395486

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 258

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	-
Atorvastatin	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6	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

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