hypercholesterolemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Trade Name: EZETROL
Pharmaceutical Form: Tablet
INN or Proposed INN: ezetimibe
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women between 18 and 79 years of age. • Patient is currently taking a stable dose of lipid-lowering agents listed below and the LDL-C prescreen value is within the range noted in Appendix 6.8. Simvastatin 5 mg, 10 mg, 20 mg, 40 mg, 80 mg* Atorvastatin 10 mg, 20 mg, 40 mg* Rosuvastatin 5 mg, 10 mg Pravastatin 10 mg, 20 mg, 40 mg Fluvastatin 20 mg, 40 mg, 80 mg Lovastatin 10 mg, 20 mg, 40 mg, 80 mg Ezetimibe 10 mg Ezetimibe 10 mg + Pravastatin 10 mg Ezetimibe 10 mg + Simvastatin 10 mg* Ezetimibe + Fluvastatin 10 /20 mg or 10/40 mg Ezetimibe + Lovastatin 10/10 mg or 10/20 mg • Patient is moderately high risk (patients with multiple (2+) risk factors that confer a 10-year risk for CHD of 10 to 20% as estimated from Framingham risk scores): Visit 2 LDL-C =100 mg/dL but =160 mg/dL (2.6 and 4.2 mmol/L) -or- Patient is high risk without atherosclerotic vascular disease (patients with CHD risk equivalents: diabetes mellitus or multiple (2+) risk factors that confer a 10-year risk for CHD >20% as estimated from Framingham risk scores): Visit 2 LDL-C =100 mg/dL but =160 mg/dL (2.6 and 4.2 mmol/L) -or- Patient is high risk with atherosclerotic vascular disease (patients with established CHD; or patients with CHD risk equivalents: diabetes mellitus or multiple (2+) risk factors that confer a 10-year risk for CHD >20% as estimated from Framingham risk scores AND other atherosclerotic vascular disease*: Visit 2 LDL-C =70 mg/dL but =160 mg/dL (1.8 and 4.2 mmol/L) 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 hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any component of these medications, or has a history of significant myopathy or rhabdomyolysis with ezetimibe or any statin. • Patient has uncontrolled hypertension (treated or untreated) with systolic blood pressure >160 mm Hg or diastolic >100 mm Hg. Investigators are encouraged to maximize blood pressure control according to current guidelines prior to randomization. • Patient has diabetes mellitus (Type 1 or 2) that is poorly controlled (HbA1c =8.5% at Visit 1 or newly diagnosed (within 3 months of Visit 1) and/or patient has recent history of repeated hypoglycemia or unstable glycemic control, or has had a change in treatment (changes in dosage or addition of new therapy) of antidiabetic pharmacotherapy or change of ±10 units of insulin, within 2 months of Visit 1. • Current use of cyclosporine, itraconazole, lopinavir or ritonavir • Current use of fibrates, niacin, or resins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Percent change from baseline in LDL-C;Main Objective: To evaluate the LDL-C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin (5 or 10 mg) (pooled across doses) compared with doubling the baseline dose of rosuvastatin (pooled) in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin (5 or 10 mg) alone and not at their NCEP ATP III LDL-C goal.; Secondary Objective: To evaluate the LDL-C lowering efficacy of the addition of ezetimibe (10 mg) to the rosuvastatin 5 mg compared with rosuvastatin 10 mg in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 5 mg alone and not at their NCEP ATP III LDL-C goal. 2. To evaluate the LDL-C lowering efficacy of the addition of ezetimibe (10 mg) to rosuvastatin 10 mg compared with rosuvastatin 20 mg in patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 10 mg alone and not at their NCEP ATP III LDL-C goal. 3. In patients with primary hypercholesterolemia at moderately high or high risk for CHD, who are treated with rosuvastatin 5 or 10 mg alone and not at their NCEP ATP III LDL-C goal: | — |
Countries
Denmark, Finland, Hungary
Outcome results
None listed