Effects of various doses of statin therapy on the endothelial function in young adults with familial hypercholesterolemia
| ISRCTN | ISRCTN47683043 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47683043 |
| Protocol serial number | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=532 |
| Sponsor | Academic Medical Center (Netherlands) |
| Funder | Academic Medical Center (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.D. Trip
Scientific
Scientific
Academic Medical Center
Department of Cardiology
F4- 109
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, crossover group trial |
| Secondary study design | Randomised controlled trial |
| 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. |
| Study acronym | EVALUATE |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | simvastatin |
| Primary outcome measure(s) |
The effect of various doses of simvastatin (5-40 mg) on endothelial function as measured by flow mediated dilatation (FMD) compared to placebo. |
| Key secondary outcome measure(s) |
The cholesterol lowering effect of the various dosages of simvastatin compared to placebo. |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
