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van CCT (UK)


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van CCT (UK)


Effects of various doses of statin therapy on the endothelial function in young adults with familial hypercholesterolemia.


- candidate number1851
- NTR NumberNTR532
- ISRCTNISRCTN47683043
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR23-nov-2005
- Secondary IDsN/A 
- Public TitleEffects of various doses of statin therapy on the endothelial function in young adults with familial hypercholesterolemia.
- Scientific TitleA double blind cross-over trial to evaluate the effects of 5-40 mg/day simvastatin therapy on the endothelial function in young adults with familial hypercholesterolemia.
- ACRONYMEVALUATE
- hypothesisA threshold reduction in LDL-C is required to improve endothelial function as measured by the flow mediated dilation (FMD).
- Healt Condition(s) or Problem(s) studiedFamilial hypercholesterolemia (FH)
- Inclusion criteriaHealthy heterozygous FH patients aged >18 years with a documented LDL receptor mutation and LDL cholesterol level above the 95th percentile for age and gender. Or LDL cholesterol above 95st percentile and a positive family history for FH or premature CAD.
- Exclusion criteriaFemales who are pregnant or intend to become pregnant; hypersensitivity or contraidication to simvastatin; excessive alcohol consumption, smoking or drug abuse.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 1-feb-2006
- planned closingdate31-jan-2008
- Target number of participants40
- InterventionsVarious doses of simvastatin (0-5-10-20-40 mg/day during 8 weeks), compared to placebo.
- Primary outcomeThe effect of various doses of simvastatin (5-40 mg) on endothelial function as measured by flow mediated dilatation (FMD) compared to placebo.
- Secondary outcomeThe cholesterol lowering effect of the various dosages simvastatin campared to placebo.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.D. Trip
- CONTACT for SCIENTIFIC QUERIESDr. Ir. M.N. Vissers
- Sponsor/Initiator Academic Medical Center (AMC), Department of Vascular Medicine
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Vascular Medicine
- PublicationsN/A
- Brief summaryIn 40 young adults with FH we will examine the effect of various dosis simvastatin (0-5-10-20-40 mg/day during 8 weeks) on the endothelial function. This will reveal whether a threshold exists for an LDL-C reduction required to improve FMD.
- Main changes (audit trail)
- RECORD23-nov-2005 - 6-mrt-2006


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