ROMEO (Rosuvastatin in Metabolic syndrOme)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00395486
First received: November 1, 2006
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome X
Drug: Rosuvastatin
Drug: Atorvastatin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Subjects Reaching Their LDL-C Target Goal [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Using laboratory test, mean change of glucose level was investigated.

  • Percentage Change of Insulin Resistance Using HOMA-R [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage reduction of LDL-C

  • Percentage Change of Total Cholesterol (TC) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage change of total cholesterol level

  • Percentage Change of High-Density Lipoprotein-C (HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage change of HDL-C level

  • Percentage Change of Triglycerides (TG) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage change of Triglycerides.

  • Percentage Change of Apolipoprotein A1 (ApoA1) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage change of Apolipoprotein A1

  • Percentage Change of Apolipoprotein B (ApoB) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Calculate the percentage change of apolipoprotein B


Enrollment: 258
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin Drug: Rosuvastatin
10mg
Other Name: Crestor
Active Comparator: Atorvastatin Drug: Atorvastatin
10mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395486

Locations
Korea, Republic of
Research Site
Pusan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: JoonWoo Bahn, MD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00395486     History of Changes
Other Study ID Numbers: D3560L00061, ROMEO
Study First Received: November 1, 2006
Results First Received: June 9, 2009
Last Updated: June 30, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:
rosuvastatin
lipoprotein
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014