Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
NCT ID: NCT01223625
Last Updated: 2010-10-19
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
2010-06-30
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/day
Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Interventions
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Rosuvastatin 5mg/day
Rosuvastatin 5mg/day
Rosuvastatin 40mg/day
Rosuvastatin 40mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. no prior treatment with statins
Exclusion Criteria
2. unconscious patients
3. serum creatinine \> 176μmol/L
4. total-cholesterol \> 7.0 mmol/l
5. hypothyreoidism ((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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Department of Cardiology, Odense University Hospital
Principal Investigators
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Rasmus Egede, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Locations
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Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark
Countries
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References
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Egede R, Jensen LO, Hansen HS, Antonsen L, Hansen KN, Junker A, Thayssen P. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients. Int J Cardiol. 2012 Jul 26;158(3):376-9. doi: 10.1016/j.ijcard.2011.01.071. Epub 2011 Feb 23.
Other Identifiers
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VF-200600
Identifier Type: -
Identifier Source: org_study_id