Metabolic SyndromePhase 4EFFORTNCT00815659
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
A Phase 4 study testing rosuvastatin in people with Metabolic Syndrome, run by AstraZeneca at 6 sites in Turkey (Türkiye).
Trial summary
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Dec 2008to Mar 2010
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
- LDL-Cholesterol > 130mg/dl
- HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
- Triglycerides < 400 mg/dl
Who cannot join
- With a concomitant coronary disease
- Currently under statin therapy or previously treated with statins within the last 6 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Research site
Ankara, Besevler
Research site
Istanbul, Haseki
Research Site
Izmir
Research site
Kayseri, Erciyes
Research site
Kocaeli, Umuttepe
Research Site
Trabzon
About this study
Official title: Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- rosuvastatin
- Keywords
- plasma lipid profile, 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
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal HDL-cholesterol Level
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Measured: Baseline
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-cholesterol Level
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Measured: Baseline
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Total Cholesterol Level
Baseline
Measured: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Triglyceride Level
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Measured: Baseline
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL
Measured: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Measured: 3 months (from enrollment to last visit)
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment
Measured: 3 months (from enrollment to last visit)
Secondary outcomes (29)
Basal Interleukin 1 (IL-1) Level
IL-1 levels before (Visit 2-enrollment)
Measured: Baseline
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Interleukin 6 (IL-6) Level
IL-6 levels before (Visit 2-enrollment)
Measured: Baseline
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Interleukin 8 (IL-8) Level
IL-8 levels before (Visit 2-enrollment)
Measured: Baseline
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Interleukin 10 (IL-10) Level
IL-10 levels before (Visit 2-enrollment)
Measured: Baseline
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Tumor Necrosis Factor (TNF) Level
TNF levels before (Visit 2-enrollment)
Measured: Baseline
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
hs-CRP levels before (Visit 2-enrollment)
Measured: Baseline
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-3 Level
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
Measured: Baseline
LDL-3 Level After 3 Months of Rosuvastatin Treatment
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-4 Level
LDL-4 levels before (Visit 2-enrollment)
Measured: Baseline
LDL-4 Level After 3 Months of Rosuvastatin Treatment
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-5 Level
LDL-5 levels before (Visit 2-enrollment)
Measured: Baseline
LDL-5 Level After 3 Months of Rosuvastatin Treatment
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-6 Level
LDL-6 levels before (Visit 2-enrollment)
Measured: Baseline
LDL-6 Level After 3 Months of Rosuvastatin Treatment
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal LDL-7 Level
LDL-7 levels before (Visit 2-enrollment)
Measured: Baseline
LDL-7 Level After 3 Months of Rosuvastatin Treatment
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Large HDL Subfraction Level
Large HDL subfraction levels before (Visit 2-enrollment)
Measured: Baseline
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Intermediate HDL Subfraction Level
Intermediate HDL subfraction levels before (Visit 2-enrollment)
Measured: Baseline
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Basal Small HDL Subfraction Level
Small HDL subfraction levels before (Visit 2-enrollment)
Measured: Baseline
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Measured: 3 months (from enrollment to last visit)
Number of Patients With Adverse Events
Number of patients with any adverse events in 3 months of rosuvastatin treatment
Measured: 3 months (from enrollment to last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionMar 2010
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 SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dilek Ural, MD, Prof, Principal investigator, Kocaeli University Faculty of Medicine Cardiology Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815659
- Sponsor's protocol ID
- D3560L00079
- Acronym
- EFFORT
- Status last verified
- Aug 2011
- First submitted
- 29 Dec 2008
- Last updated
- 31 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
- ClinicalTrials.gov ID
- NCT00815659
- Acronym / sponsor ID
- EFFORT / D3560L00079
- Conditions
- Metabolic Syndrome
- Keywords
- plasma lipid profile, metabolic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Posted 4 Jul 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 is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: rosuvastatinmedication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
- LDL-Cholesterol > 130mg/dl
- HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
- Triglycerides < 400 mg/dl
Key exclusion criteria (2 listed)
- With a concomitant coronary disease
- Currently under statin therapy or previously treated with statins within the last 6 months
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: CRESTORmedication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. | Drug | Rosuvastatin |
Primary outcome
Basal HDL-cholesterol Level
Time frame: Baseline
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-cholesterol Level
Time frame: Baseline
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Total Cholesterol Level
Time frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Baseline
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Triglyceride Level
Time frame: Baseline
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment
29 secondary outcomes
Basal Interleukin 1 (IL-1) Level
Time frame: Baseline
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 6 (IL-6) Level
Time frame: Baseline
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 8 (IL-8) Level
Time frame: Baseline
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Interleukin 10 (IL-10) Level
Time frame: Baseline
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Tumor Necrosis Factor (TNF) Level
Time frame: Baseline
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
Time frame: Baseline
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal LDL-3 Level
Time frame: Baseline
LDL-3 Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal LDL-4 Level
Time frame: Baseline
LDL-4 Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal LDL-5 Level
Time frame: Baseline
LDL-5 Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal LDL-6 Level
Time frame: Baseline
LDL-6 Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal LDL-7 Level
Time frame: Baseline
LDL-7 Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Large HDL Subfraction Level
Time frame: Baseline
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Intermediate HDL Subfraction Level
Time frame: Baseline
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Basal Small HDL Subfraction Level
Time frame: Baseline
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Time frame: 3 months (from enrollment to last visit)
Number of Patients With Adverse Events
Time frame: 3 months (from enrollment to last visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dilek Ural, MD, Prof principal investigator
Kocaeli University Faculty of Medicine Cardiology Dept
6 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 in people with Metabolic Syndrome, run by AstraZeneca at 6 sites in Turkey (Türkiye).
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 4 inclusion and 2 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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 4 Jul 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?
Basal HDL-cholesterol Level (time frame: Baseline). The study lists 11 primary outcomes in all. 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 31 Aug 2011.