Metabolic Syndrome XPhase 4NCT00395486
ROMEO (Rosuvastatin in Metabolic syndrOme)
A Phase 4 study testing Rosuvastatin and Atorvastatin in people with Metabolic Syndrome X, run by AstraZeneca at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Rosuvastatin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Pusan
Research Site
Seoul
Research Site
Suwon
About this study
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
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.
- Conditions
- Metabolic Syndrome X
- Being tested
- Rosuvastatin, Atorvastatin
- Keywords
- rosuvastatin, lipoprotein, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
10mg
AtorvastatinDrug
10mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (11)
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).
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Percentage Change of Glucose Level
Using laboratory test, mean change of glucose level was investigated.
Measured: Baseline and 6 weeks
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
Measured: Baseline and 6 weeks
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)].
Measured: Baseline and 6 weeks
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)
Calculate the percentage reduction of LDL-C
Measured: Baseline and 6 weeks
Percentage Change of Total Cholesterol (TC)
Calculate the percentage change of total cholesterol level
Measured: Baseline and 6 weeks
Percentage Change of High-Density Lipoprotein-C (HDL-C)
Calculate the percentage change of HDL-C level
Measured: Baseline and 6 weeks
Percentage Change of Triglycerides (TG)
Calculate the percentage change of Triglycerides.
Measured: Baseline and 6 weeks
Percentage Change of Apolipoprotein A1 (ApoA1)
Calculate the percentage change of Apolipoprotein A1
Measured: Baseline and 6 weeks
Percentage Change of Apolipoprotein B (ApoB)
Calculate the percentage change of apolipoprotein B
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JoonWoo Bahn, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395486
- Sponsor's protocol ID
- D3560L00061
- Other IDs
- ROMEO
- Status last verified
- Jun 2011
- First submitted
- 1 Nov 2006
- Last updated
- 11 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00395486
- Acronym / sponsor ID
- D3560L00061
- Conditions
- Metabolic Syndrome X
- Keywords
- rosuvastatin, lipoprotein, metabolic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Nov 2006 (estimated)
- Results
- Posted 16 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin |
| Atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of 3 or more of the following criteria;
- Elevated LDL-C ;
- Triglyceride < 500 mg/dL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor10mg | Drug | Rosuvastatin |
| Atorvastatin10mg | Drug | Atorvastatin |
Primary outcome
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.
11 secondary outcomes
Percentage of Subjects Reaching Their LDL-C Target Goal
Time frame: Baseline and 6 weeks
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
Percentage Change of Glucose Level
Time frame: Baseline and 6 weeks
Percentage Change of Insulin Resistance Using HOMA-R
Time frame: Baseline and 6 weeks
Percentage Change of Insulin Resistance Using QUICKI
Time frame: Baseline and 6 weeks
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)
Time frame: Baseline and 6 weeks
Percentage Change of Total Cholesterol (TC)
Time frame: Baseline and 6 weeks
Percentage Change of High-Density Lipoprotein-C (HDL-C)
Time frame: Baseline and 6 weeks
Percentage Change of Triglycerides (TG)
Time frame: Baseline and 6 weeks
Percentage Change of Apolipoprotein A1 (ApoA1)
Time frame: Baseline and 6 weeks
Percentage Change of Apolipoprotein B (ApoB)
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metabolic Syndrome X
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JoonWoo Bahn, MD study director
AstraZeneca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Atorvastatin in people with Metabolic Syndrome X, run by AstraZeneca at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.