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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23698

Enrollment

Registered

2005-11-23

Start date

2006-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Various doses of simvastatin (0-5-10-20-40 mg/day during 8 weeks), compared to placebo.

Eligibility

Inclusion criteria

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 95st percentile and a positive family history for FH or premature CAD.

Exclusion criteria

Exclusion criteria: Females who are pregnant or intend to become pregnant; hypersensitivity or contraidication to simvastatin; excessive alcohol consumption, smoking or drug abuse.

Design outcomes

Primary

Measure	Time frame
The effect of various doses of simvastatin (5-40 mg) on endothelial function as measured by flow mediated dilatation (FMD) compared to placebo.	—

Secondary

Measure	Time frame
The cholesterol lowering effect of the various dosages simvastatin campared to placebo.	—

Contacts

Public ContactM.D. Trip

Academic Medical Center (AMC), Department of Cardiology, F4- 109, P.O. Box 22660

m.d.trip@amc.uva.nl+31 (0)20 5665882 or 020-5669111

Outcome results