ROMEO (Rosuvastatin in Metabolic syndrOme)

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

Criteria

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