Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.D. Trip

ORCID ID

Contact details

Academic Medical Center
Department of Cardiology
F4- 109
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

Sponsor information

Organisation

Academic Medical Center (Netherlands)

Sponsor details

Department of Vascular Medicine
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes