ROMEO (Rosuvastatin in Metabolic syndrOme)

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

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 Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
  • Suwon, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atorvastatin	Drug: Atorvastatin; 10mg
Experimental: Rosuvastatin	Drug: Rosuvastatin; 10mg; Other Names: Crestor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: JoonWoo Bahn, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: November 1, 2006
• First Submitted That Met QC Criteria: November 2, 2006
• First Posted (Estimate): November 3, 2006

Study Record Updates

• Last Update Posted (Estimate): July 11, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: metabolic syndrome; rosuvastatin; lipoprotein
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: D3560L00061; ROMEO