Hypercholesterolaemia, Hyperlipidaemia
Conditions
Brief summary
In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl\>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).
Interventions
DRUGMK-0653, ezetimibe
DRUGDuration of Treatment: 3 months
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations).
Exclusion criteria
* pregnant or breast feeding women * Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (\>200 mg/day) and fibrates taken within the 3 months preceding visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups. | — |
Outcome results
None listed