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 |
| Secondary identifying numbers | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=532 |
- 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
| Study design | Randomised, double blind, placebo controlled, crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | simvastatin |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Academic Medical Center (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Vascular Medicine
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
