Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=532
Study information
Scientific title
A 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.
Acronym
EVALUATE
Study hypothesis
A threshold reduction in low density lipoprotein cholesterol (LDL-C) is required to improve endothelial function as measured by the flow mediated dilation (FMD).
Ethics approval
Received from local medical ethics committee
Study design
Randomised, double blind, placebo controlled, crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Familial hypercholesterolemia (FH)
Intervention
Various doses of simvastatin (0-5-10-20-40 mg/day during 8 weeks), compared to placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
simvastatin
Primary outcome measures
The effect of various doses of simvastatin (5-40 mg) on endothelial function as measured by flow mediated dilatation (FMD) compared to placebo.
Secondary outcome measures
The cholesterol lowering effect of the various dosages of simvastatin compared to placebo.
Overall trial start date
01/02/2006
Overall trial end date
31/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy 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 95th percentile and a positive family history for FH or premature CAD.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Females who are pregnant or intend to become pregnant
2. Hypersensitivity or contraindication to simvastatin
3. Excessive alcohol consumption, smoking or drug abuse
Recruitment start date
01/02/2006
Recruitment end date
31/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary