Mixed Hyperlipidemia MedDRA version: 9.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia
Conditions
Interventions
Product Name: MK0524A (ER-Niacin/MK-0524)
Product Code: MK0524A (ER-Niacin/MK-0524)
Pharmaceutical Form: Tablet
INN or Proposed INN: nicotinic acid
CAS Number: 59-67-6
Concentration unit: g gram(s)
Co
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patient is male or female =18 and = 80 years of age on day of signing informed consent. b) Patient meets one of the following criteria (based on NCEP ATP III categorization of CHD risk) at Visit 2 : Following Washout of Previous Lipid-Lowering Therapy Multiple Risk Patient has been washed out of a statin or other lipid-modifying therapy and has multiple risk factors (=2 RF) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L). Low Risk Patient has been washed off of a statin or other lipid-modifying therapy and is low risk (0-1 RF) with an LDL-C =130 mg/dL and =190 mg/dL (3.4 and 5.0 mmol/L). Naïve patients (not currently on lipid-lowering therapy) High Risk Patient is not on a statin or other lipid-modifying therapy and is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L). Multiple Risk Patient is not on a statin or other lipid-modifying therapy and has multiple risk factors (=2 RF) with an LDL-C =130 mg/dL and =160 mg/dL (3.4 and 4.1 mmol/L). Low Risk Patient is not on a statin or other lipid-modifying therapy and is low risk (0-1 RF) an LDL-C =130 mg/dL and =190 mg/dL (3.4 and 5.0 mmol/L). c) Triglycerides (TG) concentrations =150 mg/dL to =500 mg/dL (1.7 - 5.6 mmol/L) at Visit 2. 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: 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 • Abnormal TSH Patient with Type 1 or Type 2 diabetes mellitus and: • is poorly controlled (HbA1C at Screening >8%) • is newly diagnosed (within 3 months of Visit 1) • is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± 10 units of insulin) within 3 months of Visit 2. • is taking lipid altering therapy which would require washout prior to study participation. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism). Patient has a history of hypersensitivity or allergic reaction to niacin or niacin-containing Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.products, simvastatin, or atorvastatin. Patient is on lipid-modifying agents including fish oils >500 mg, bile-acid sequestrants, HMG-CoA reductase inhibitors, ezetimibe, ezetimibe/simvastatin, Cholestin™ and other red rice yeast products within 6 weeks and fibrates within 8 weeks prior to Visit 2. Patients are eligible for participation in this study ONLY after the prespecified washout period as indicated. Patient is a woman currently taking hormonal contraceptives or intermittent use of HRTs (e.g., estradiol, medroxyprogesterone, progesterone). Patient is taking the following antioxidant vitamins: Vitamin C in excess of 1500 mg/day Vitamin E in excess of 45 IU/day for men, 36 IU for women Beta Carotene 15000 IU for men 12000 IU/day for women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: In patients with mixed hyperlipidemia, to evaluate the effect of MK 0524B (dosed as MK-0524A coadministered with simvastatin) compared to atorvastatin in the percent reduction from baseline in the LDL-C/HDL-C ratio after 12 weeks of treatment for the following dose comparisons: 2g/20 mg MK-0524B vs. 10 mg atorvastatin, 2g/40 mg MK-0524B vs. 20 mg atorvastatin, 2g/40 mg MK-0524B vs. 40 mg atorvastatin, and 2g/40 mg MK-0524B vs. 80 mg atorvastatin. ;Secondary Objective: In patients with mixed hyperlipidemia: To evaluate the effect of MK-0524Bcompared to atorvastatin on increasing HDL-C after 12 weeks of treatment . To evaluate the effect of MK 0524B (dosed as MK-0524A coadministered with simvastatin) compared to atorvastatin on decreasing triglycerides after 12 weeks of treatment. To evaluate the effect of MK 0524B (dosed as MK-0524A coadministered with simvastatin) compared to atorvastatin on decreasing non-HDL-C after 12 weeks of treatment. To evaluate the effect of MK-0524B (dosed as MK-0524A coadministered with simvastatin) compared to atorvastatin on decreasing LDL-C after 12 weeks of treatment. To evaluate the effect of MK 0524B (dosed as MK-0524A coadministered with simvastatin) compared to atorvastatin on Apo B, Apo A-I, lipoprotein and apolipoprotein ratios, Lp(a), and CRP after 12 weeks of treatment. To assess the safety and tolerability of MK-0524B (dosed as MK-0524A coadministered with simvastatin).;Primary end point(s): The primary efficacy parameter is the percent change from baseline in LDL-C/HDL-C ratio following 12 weeks of active treatment. In addition, LDL-C, HDL-C, total cholesterol, triglycerides, non-HDL-C, Apo B, Apo A-1, lipoprotein and apolipoprotein ratios, Lp(a), and CRP will be assessed in all patients. | — |
Countries
Finland, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed