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
2 other identifiers
interventional
258
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
June 16, 2011
CompletedJuly 11, 2011
June 1, 2011
1.8 years
November 1, 2006
June 9, 2009
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Percentage of Subjects Reaching Their LDL-C Target Goal
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
Baseline and 6 weeks
Percentage Change of Glucose Level
Baseline and 6 weeks
Percentage Change of Insulin Resistance Using HOMA-R
Baseline and 6 weeks
Percentage Change of Insulin Resistance Using QUICKI
Baseline and 6 weeks
- +6 more secondary outcomes
Study Arms (2)
Rosuvastatin
EXPERIMENTALAtorvastatin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Pusan, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
JoonWoo Bahn, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 3, 2006
Study Start
September 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 11, 2011
Results First Posted
June 16, 2011
Record last verified: 2011-06