ROMEO (Rosuvastatin in Metabolic syndrOme)

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395486
• Other study ID #: D3560L00061
• Secondary ID: ROMEO
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2006
• Last updated: June 30, 2011
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Rosuvastatin
10mg
• Atorvastatin
10mg

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Pusan
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 6 weeks	No
Secondary	Percentage of Subjects Reaching Their LDL-C Target Goal	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).	Baseline and 6 weeks	No
Secondary	Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal	Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.	Baseline and 6 weeks	No
Secondary	Percentage Change of Glucose Level	Using laboratory test, mean change of glucose level was investigated.	Baseline and 6 weeks	No
Secondary	Percentage Change of Insulin Resistance Using HOMA-R	HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5	Baseline and 6 weeks	No
Secondary	Percentage Change of Insulin Resistance Using QUICKI	QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].	Baseline and 6 weeks	No
Secondary	Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)	Calculate the percentage reduction of LDL-C	Baseline and 6 weeks	No
Secondary	Percentage Change of Total Cholesterol (TC)	Calculate the percentage change of total cholesterol level	Baseline and 6 weeks	No
Secondary	Percentage Change of High-Density Lipoprotein-C (HDL-C)	Calculate the percentage change of HDL-C level	Baseline and 6 weeks	No
Secondary	Percentage Change of Triglycerides (TG)	Calculate the percentage change of Triglycerides.	Baseline and 6 weeks	No
Secondary	Percentage Change of Apolipoprotein A1 (ApoA1)	Calculate the percentage change of Apolipoprotein A1	Baseline and 6 weeks	No
Secondary	Percentage Change of Apolipoprotein B (ApoB)	Calculate the percentage change of apolipoprotein B	Baseline and 6 weeks	No