Hypercholesterolemia or Mixed Dyslipidemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Product Name: MK-0524A (ER-Niacin/MK-0524) or MK0524 (ER-Niacin/Laropiprant)
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinic Acid
Other descr
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must have their LDL-C value above their goal (based on NCEP ATP III Guidelines) when on a stable dose of statin defined by the protocol: • Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C >100 mg/dL and =130 mg/dL (2.7 mmol/L and 3.4 mmol/L). • Patient has multiple risk factors (=2 RF) with an LDL-C >130 mg/dL and =160 mg/dL (3.4 mmol/L and 4.1 mmol/L). • Patient is low risk (0 to 1 RF) with an LDL-C >160 mg/dL and =190 mg/dL (4.1 mmol/L and 5.0 mmol/L). 2. Patient with diabetes mellitus must have a confirmed diagnosis and been on a stable dose of antidiabetic pharmacotherapy for 3 months prior to the study. 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: 1. Patient has a history of hypersensitivity or allergic reaction to niacin or niacin-containing products, simvastatin, or atorvastatin. 2. Patient has uncontrolled/unstable cardiac arrhythmias, or unstable hypertension 3. Patient has taken torcetrapib alone or in combination and the last dose was within 1 year of Visit 1. 4. Patient has the following exclusionary laboratory values at Visit 1. • Creatinine >2.0 mg/dL (177 micromol/L) • ALT (SGPT) >1.5 x ULN • AST (SGOT) >1.5 x ULN • CK >2 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the LDL-C lowering efficacy of the addition of ER niacin/laropiprant to simvastatin or atorvastatin (pooled) compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with primary hypercholesterolemia or mixed dyslipidemia who are not at their NCEP ATP III LDL-C goal.;Secondary Objective: To evaluate other lipid efficacy of the addition of ER niacin/laropiprant to simvastatin or atorvastatin (pooled) compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with primary hypercholesterolemia or mixed dyslipidemia who are not at their NCEP ATP III LDL-C goal.;Primary end point(s): The primary end point is the percent change from baseline in LDL-C at Week 12. The baseline is defined as Day 1 (randomization visit) measurement. | — |
Countries
Austria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden
Outcome results
None listed