Hypercholesterolemia and Mixed Dyslipidemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Product Name: MK- 524B (ER Niacin/Laropiprant/Simvastatin
Product Code: MK-524B
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinic Acid
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Merck, Sharp & Dohme Ireland (Human Health) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is male or female =18 and =85 years of age on day of signing informed consent. Patient has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values (within 6 months of screening), or as otherwise determined by the investigator through optional lipid measurements at screening visit (Visit 1 or prior to washout period). Patient meets one of the following triglyceride (TG) criteria: a. Patient is on niacin, statin, or fibrate and has TG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is high risk (CHD or CHD risk equivalent based on NCEP ATP III) AND is on a statin. Note: High risk patients not currently being treated with a statin are eligible Patient is on a statin dose with equivalent or greater LDL-C-lowering efficacy than that of simvastatin 80 mg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the LDL-C-lowering effects and evaluate the HDL-C-raising effects of MK-0524B combination tablet versus coadministered MK-0524A and Simvastatin.;Secondary Objective: Evaluate the HDL-C-raising effects of MK-0524B combination tablet versus coadministered MK-0524A and Simvastatin.;Primary end point(s): Change in LDL-C from Baseline (Visit 2) Change in HDL-C from Baseline (Visit 2) | — |
Countries
Austria, France, Germany, Hungary, Ireland, Lithuania, Sweden
Outcome results
None listed