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NCT Number: NCT00395486

ROMEO (Rosuvastatin in Metabolic syndrOme)

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Pusan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

10mg

Other names: Crestor

atorvastatin

Drug

10mg

Primary outcomes

  1. Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6

    Time frame: 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 outcomes

  1. Percentage of Subjects Reaching Their LDL-C Target Goal

    Time frame: 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).

  2. Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal

    Time frame: Baseline and 6 weeks

    Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.

  3. Percentage Change of Glucose Level

    Time frame: Baseline and 6 weeks

    Using laboratory test, mean change of glucose level was investigated.

  4. Percentage Change of Insulin Resistance Using HOMA-R

    Time frame: 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

  5. Percentage Change of Insulin Resistance Using QUICKI

    Time frame: 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)].

  6. Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)

    Time frame: Baseline and 6 weeks

    Calculate the percentage reduction of LDL-C

  7. Percentage Change of Total Cholesterol (TC)

    Time frame: Baseline and 6 weeks

    Calculate the percentage change of total cholesterol level

  8. Percentage Change of High-Density Lipoprotein-C (HDL-C)

    Time frame: Baseline and 6 weeks

    Calculate the percentage change of HDL-C level

  9. Percentage Change of Triglycerides (TG)

    Time frame: Baseline and 6 weeks

    Calculate the percentage change of Triglycerides.

  10. Percentage Change of Apolipoprotein A1 (ApoA1)

    Time frame: Baseline and 6 weeks

    Calculate the percentage change of Apolipoprotein A1

  11. Percentage Change of Apolipoprotein B (ApoB)

    Time frame: Baseline and 6 weeks

    Calculate the percentage change of apolipoprotein B

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 3, 2006
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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