No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
The cholesterol lowering effect of the various dosages simvastatin campared to placebo.
Background summary
In 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.
Study objective
A threshold reduction in LDL-C is required to improve endothelial function as measured by the flow mediated dilation (FMD).
Intervention
Various doses of simvastatin (0-5-10-20-40 mg/day during 8 weeks), compared to placebo.
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
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
Females who are pregnant or intend to become pregnant; hypersensitivity or contraidication to simvastatin; excessive alcohol consumption, smoking or drug abuse.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL490 |
| NTR-old | NTR532 |
| Other | : N/A |
| ISRCTN | ISRCTN47683043 |