A Multicenter, Randomized, Double-Blind, Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia. - MK-0524B Lipid Study
- Conditions
- Hypercholesterolemia and Mixed DyslipidemiaMedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia
- Registration Number
- EUCTR2007-002516-26-IE
- Lead Sponsor
- Merck, Sharp & Dohme Ireland (Human Health) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2370
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 <500 mg/dL (5.65 mmol/L) at or within 6 months of washout (Pre-screen visit).
b.Patient is not on any lipid-modifying therapy or is on lipid-modifying therapy other than niacin, statin, or fibrate and has TG <600 mg/dL (6.78 mmol/L) at or within 6 months of screening (Visit 1 for naïve patients or Prescreen visit for washout patients).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>Change in HDL-C from Baseline (Visit 2)<br>
- Secondary Outcome Measures
Name Time Method