Status:
COMPLETED
ROMEO (Rosuvastatin in Metabolic syndrOme)
Lead Sponsor:
AstraZeneca
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00395486
Start Date
September 1 2006
End Date
June 1 2008
Last Update
July 11 2011
Active Locations (3)
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1
Research Site
Pusan, South Korea
2
Research Site
Seoul, South Korea
3
Research Site
Suwon, South Korea