Hypercholesterolemia MedDRA version: 8.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Product Name: MK-0524A (ER-Niacin/MK-0524)
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinic Acid
CAS Number: 59-67-6
Current Sponsor code: N/A
Other descriptive name: ER-Ni
Sponsors
Merck & Co
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is appropriate candidate for niacin therapy. Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregannt are excluded. Patients with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g.;Secondary Objective: 1)To demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g. 2)To assess the safety and tolerability of MK-0524A. ;Primary end point(s): The primary endpoint of maximum GFSS categorized into none/mild, moderate, severe, extreme during the first 7 days following a 5 day drug holiday period will be compared between the MK-0524A/Placebo/MK-0524A treatment group and the MK-0524A/Placebo/ER-Niacin group using the Cochran-Mantel-Haenszel (CMH) test stratified by country. | — |
Countries
Austria, Germany, Italy, United Kingdom
Outcome results
None listed