primaire hypercholesterolemie of gemengde dyslipidemie Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia
Conditions
Interventions
DOSAGE/DOSAGE FORM, ROUTE, AND DOSE REGIMEN
All study medication products used in this study will be provided by the
Sponsor. ERN/LRPT/SIM 1 g/10 mg and ERN/LRPT 1 g tablets will be in the same
imag
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is male or female >=18 and
Exclusion criteria
Exclusion criteria: 1. Patient consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week. 2. Patient has the following exclusionary central laboratory values. Creatinine clearance (eGFR) 1.5 x upper limit of normal (ULN) AST (SGOT) >1.5 x ULN CK >2 x ULN. 3. Patient is high risk (CHD or CHD risk equivalent based on NCEP ATP III) AND is on a LMT at Visit 1. Note: High risk patients not currently being treated with a LMT at Visit 1 are eligible. 4. Patient is on simvastatin 40 mg, or another LMT dose of equivalent or greater LDLC lowering efficacy than that of simvastatin 40 mg. 5. Patient with Type 1 or Type 2 diabetis mellitus and: is on statin therapy is poorly controlled (HbA1C>8%) is newly diagnosed (within 3 months of Visit 1) has recently experienced repeated hypoglycemia or unstable glycemic control is taking new or recently adjusted anti-diabetic pharmacotherapy (with the exception of =6 weeks prior to the randomization visit. Hypothyroidism is defined as having a TSH >20% above the central laboratory*s upper limit of the normal reference range (>6.0 mclU/ml) 8. Patient has nephrotic syndrome or other clinically significant renal disease. 9. Patient has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled/unstable cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg Note: The anti-hypertensive medications of a patient can be managed during the screening period and BP measurements can be repeated at subsequent visits prior to randomization. 10. Patient has had active peptic ulcer disease 50 mg/day, bile-acid sequestrants, HMG-CoA reductase inhibitors, ezetimibe, CHOLESTIN , and other red yeast rice pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the primary hypothesis, ERN/LRPT/SIM 2g/20 mg will be considered equivalent to ERN/LRPT 2g coadministered with simvastatin 20 mg if the 95% CI in LDL-C reduction for the difference between these two treatments falls within (-4%, 4%) interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary hypothesis of equivalence in raising HDL-C will be tested using a similar ANOVA analysis, described above, applied to percent change from baseline to the end of the 8-week treatment period in HDL-C. The equivalence of ERN/LRPT/SIM 2g/20 mg and ERN/LRPT 2 g coadministered with SIM 20 mg in increasing HDL-C will be established if the 95% CI for the respective between-treatment difference in percent change from baseline in HDL-C falls within ±4%. | — |
Countries
Netherlands
Outcome results
None listed