Phase 4
Completed N=258
ROMEO (Rosuvastatin in Metabolic syndrOme)
Metabolic Syndrome X
Source: ClinicalTrials.gov NCT00395486 ↗
Enrolled (actual)
258
Serious AEs
1.6%
Results posted
Jun 2011
Primary outcomePrimary: Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 — -44.40; -36.50 percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 |
-44.40; -36.50 | — |
| SECONDARY Percentage of Subjects Reaching Their LDL-C Target Goal |
88.20; 75.40 | — |
| SECONDARY Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal |
78.80; 66.70 | — |
| SECONDARY Percentage Change of Glucose Level |
-0.60; 2.78 | — |
| SECONDARY Percentage Change of Insulin Resistance Using HOMA-R |
28.00; 50.30 | — |
| SECONDARY Percentage Change of Insulin Resistance Using QUICKI |
-1.27; -1.03 | — |
| SECONDARY Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) |
-45.50; -37.90 | — |
| SECONDARY Percentage Change of Total Cholesterol (TC) |
-34.10; -28.80 | — |
| SECONDARY Percentage Change of High-Density Lipoprotein-C (HDL-C) |
9.90; 8.20 | — |
| SECONDARY Percentage Change of Triglycerides (TG) |
-17.20; -15.10 | — |
| SECONDARY Percentage Change of Apolipoprotein A1 (ApoA1) |
8.50; 4.20 | — |
| SECONDARY Percentage Change of Apolipoprotein B (ApoB) |
-40.50; -34.60 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00395486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.