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ROMEO (Rosuvastatin in Metabolic syndrOme)

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring rosuvastatin, lipoprotein, metabolic syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvastatin

Atorvastatin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Percentage Change of Glucose Level
Using laboratory test, mean change of glucose level was investigated.
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
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)].
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)
Calculate the percentage reduction of LDL-C
Percentage Change of Total Cholesterol (TC)
Calculate the percentage change of total cholesterol level
Percentage Change of High-Density Lipoprotein-C (HDL-C)
Calculate the percentage change of HDL-C level
Percentage Change of Triglycerides (TG)
Calculate the percentage change of Triglycerides.
Percentage Change of Apolipoprotein A1 (ApoA1)
Calculate the percentage change of Apolipoprotein A1
Percentage Change of Apolipoprotein B (ApoB)
Calculate the percentage change of apolipoprotein B

Full Information

First Posted
November 1, 2006
Last Updated
June 30, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00395486
Brief Title
ROMEO (Rosuvastatin in Metabolic syndrOme)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
rosuvastatin, lipoprotein, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Title
Atorvastatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
10mg
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
10mg
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Reaching Their LDL-C Target Goal
Description
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).
Time Frame
Baseline and 6 weeks
Title
Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal
Description
Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Glucose Level
Description
Using laboratory test, mean change of glucose level was investigated.
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Insulin Resistance Using HOMA-R
Description
HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Insulin Resistance Using QUICKI
Description
QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].
Time Frame
Baseline and 6 weeks
Title
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)
Description
Calculate the percentage reduction of LDL-C
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Total Cholesterol (TC)
Description
Calculate the percentage change of total cholesterol level
Time Frame
Baseline and 6 weeks
Title
Percentage Change of High-Density Lipoprotein-C (HDL-C)
Description
Calculate the percentage change of HDL-C level
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Triglycerides (TG)
Description
Calculate the percentage change of Triglycerides.
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Apolipoprotein A1 (ApoA1)
Description
Calculate the percentage change of Apolipoprotein A1
Time Frame
Baseline and 6 weeks
Title
Percentage Change of Apolipoprotein B (ApoB)
Description
Calculate the percentage change of apolipoprotein B
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoonWoo Bahn, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Pusan
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

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ROMEO (Rosuvastatin in Metabolic syndrOme)

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