ROMEO (Rosuvastatin in Metabolic syndrOme)

AstraZeneca258 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Metabolic Syndrome X

Interventions

RosuvastatinDRUG

10mg

AtorvastatinDRUG

10mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Pusan, South Korea

Research Site

Seoul, South Korea

Research Site

Suwon, South Korea

Outcomes

Primary Outcomes

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.