Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)
NCT ID: NCT01203982
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
87 participants
INTERVENTIONAL
2007-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rosuvastatin 5mg
Rosuvastatin 5mg/day
Rosuvastatin
Rosuvastatin 5mg/day for one year
Rosuvastatin 40mg
Rosuvastatin 40mg/day
Rosuvastatin
Rosuvastatin 40mg/day for one year
Interventions
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Rosuvastatin
Rosuvastatin 5mg/day for one year
Rosuvastatin
Rosuvastatin 40mg/day for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. no prior treatment with statins and
3. a non significant lesion in one of the two non-culprit coronary arteries. -
Exclusion Criteria
2. unconscious patients,
3. serum creatinine \> 176μmol/L,
4. total-cholesterol \> 7.0 mmol/l,
5. hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)),
6. current liver disease (ALAT \> 2 x ULN),
7. unexplained creatine kinase \> 3 x ULN,
8. alcohol or drug abuse within the last five years,
9. prior myopathy or serious hypersensitivity reaction caused by statins,
10. women with childbearing potential who were not using chemical or mechanical contraception,
11. pregnant or breastfeeding women,
12. history of malignancy unless a disease-free period of more than five years was present,
13. patients with abnormal lung function test (LFT),
14. participation in another investigational drug study less than four weeks before enrolment in the present study,
15. treatment with cyclosporine or fibrates. -
18 Years
81 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Odense University Hospital
Locations
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Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark
Countries
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Other Identifiers
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VF-20060060
Identifier Type: -
Identifier Source: org_study_id