At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 80 years
- ✓Mixed hyperlipidemia diagnosis
- ✓LDL cholesterol 130–190 mg/dL
- ✓Triglycerides 150–500 mg/dL
- ✕Pregnant or lactating women, or women intending to become pregnant
- ✕Poorly controlled, newly diagnosed, or recently adjusted diabetes mellitus (except insulin ±10 units)
- ✕HIV positive
- ✕Cardiovascular event within past 3 months (myocardial infarction, stroke, bypass surgery, unstable angina, angioplasty)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK0524B Versus Atorvastatin in Patients With Mixed Hyperlipidemia
In Brief
A Phase 3 clinical trial evaluating MK-0524A, Atorvastatin, and 1 other intervention for Mixed Hyperlipidemia. Completed, enrolled 2,340 participants.
Detailed Summary
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.