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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00395486

Enrollment

258

Registered

2006-11-03

Start date

2006-09-30

Completion date

2008-06-30

Last updated

2011-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

rosuvastatin, lipoprotein, metabolic syndrome

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.

Interventions

DRUGRosuvastatin

10mg

DRUGAtorvastatin

10mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6	Baseline and 6 weeks	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.

Secondary

Measure	Time frame	Description
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	Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.
Percentage Change of Glucose Level	Baseline and 6 weeks	Using laboratory test, mean change of glucose level was investigated.
Percentage Change of Insulin Resistance Using HOMA-R	Baseline and 6 weeks	HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin\* glucose/22.5
Percentage Change of Insulin Resistance Using QUICKI	Baseline and 6 weeks	QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/\[log(insulin) + log(glucose)\].
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)	Baseline and 6 weeks	Calculate the percentage reduction of LDL-C
Percentage of Subjects Reaching Their LDL-C Target Goal	Baseline and 6 weeks	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).
Percentage Change of High-Density Lipoprotein-C (HDL-C)	Baseline and 6 weeks	Calculate the percentage change of HDL-C level
Percentage Change of Triglycerides (TG)	Baseline and 6 weeks	Calculate the percentage change of Triglycerides.
Percentage Change of Apolipoprotein A1 (ApoA1)	Baseline and 6 weeks	Calculate the percentage change of Apolipoprotein A1
Percentage Change of Apolipoprotein B (ApoB)	Baseline and 6 weeks	Calculate the percentage change of apolipoprotein B
Percentage Change of Total Cholesterol (TC)	Baseline and 6 weeks	Calculate the percentage change of total cholesterol level

Countries

South Korea

Participant flow

Recruitment details

A total of 613 subjects were enrolled in the study at 13 centres, of whom 258 were randomized to treatment with rosuvastatin (n=132) or atorvastatin (n=126). Subjects were recruited throughout South Korea from September 2006 to June 2008.

Pre-assignment details

Enrolled patients to be randomized should complete 6-week dietary run-in periods. Also, LDL level should be ≥ 130mg/dl & \< 220mg/dl and triglyceride should be \< 500mg/dl.

Participants by arm

Arm	Count
Rosuvastatin 10mg	132
Atorvastatin 10mg	126
Total	258

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	2
Overall Study	Lost to Follow-up	0	1
Overall Study	Withdrawal by Subject	5	2

Baseline characteristics

Characteristic	Rosuvastatin	Atorvastatin	Total
Age Continuous 18 years	57.5 years STANDARD_DEVIATION 10	60.4 years STANDARD_DEVIATION 9	58.9 years STANDARD_DEVIATION 9.5
Sex: Female, Male Female	74 Participants	88 Participants	162 Participants
Sex: Female, Male Male	58 Participants	38 Participants	96 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 129	0 / 124
serious Total, serious adverse events	0 / 129	4 / 124

Outcome results

Primary

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.