Hypercholesterolaemia MedDRA version: 8.0 Level: LLT Classification code 10020603
Conditions
Interventions
Product Name: MK-0524A (ER-Niacin/MK-0524) 1g/20mg Tablets
MK-0524A
Product Code: MK-0524A (ER-Niacin/MK-0524) 1g/20mg or MK-0524A
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MK-0524 or L-000888839-000E
Other des
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia with LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Catetory II) and triglycerides = 350 mg/dL. 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
Exclusion criteria
Exclusion criteria: A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients with <80% compliance, patients with certain medical conditions including those with a history of CHD/CHD equivalent or diabetes, patients taking certain concomitant medications and/or with unstable doses of medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate: The LDL-C lowering efficacy of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to MK-0524A 2g. ;Secondary Objective: In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate: The effects of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to simvastatin (pooled across doses of 20 and 40 mg) on HDL-C, TG, LDL-C, LDL-C:HDL-C ratio, non-HDL-C, Apo B, and Apo A-I. The effects of MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) compared to MK-0524A 2g on HDL-C, TG, LDL-C:HDL-C ratio, non-HDL-C, Apo B, and Apo A-I. Safety and tolerability of MK-0524B Other secondary objectives: In patients with primary hypercholesterolemia or mixed hyperlipidemia, evaluate: Assess the effects of MK-0524B on TC, Lp(a), TC:HDL ratio, RLP-C, CRP, Apo C-III, VLDL-C, and lipid subfractions. ;Primary end point(s): In patients with primary hypercholesterolemia or mixed hyperlipidemia MK-0524B 2g (pooled across simvastatin doses of 20 and 40 mg) will produce greater reductions in LDL-C than MK-0524A 2g. | — |
Countries
Denmark, Lithuania, Sweden, United Kingdom
Outcome results
None listed