Mixed hyperlipidemia MedDRA version: 7.0 Level: LLT Classification code 10027762
Conditions
Interventions
Product Name: VYTORIN
Product Code: MK0653a
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe/Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has an LDL-C 130 through 220 mg/dL (3.37 through 5.70 mmol/L) for non-diabetics; LDL-C 100 through 180 mg/dL (2.59 through 4.66 mmol/L) for diabetics, at Visit 2. b. Patient has triglycerides 150 through 500 mg/dL (1.71 through 5.70 mmol/L). [per central laboratory reference ranges] at Visit 2. c. Patient has creatine phosphokinase (CPK) =2 x upper limit of normal (ULN) [per central laboratory reference ranges] at Visit 2. d. Patient has alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =1.5 x upper limit of normal (ULN) [per central laboratory reference ranges] at Visit 2. Are the trial subjects under 18? 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. You are less than 18 years of age or greater than 79 years of age. b. You are pregnant, breastfeeding, or planning to become pregnant during this study. c. You are a woman able to become pregnant and are not willing to use an acceptable method of birth control. You must be willing to use this birth control starting at Visit 1 and continuing 14 days past the last study dose. The study doctor or staff will discuss which methods of birth control are acceptable for this study. d. You are a woman and have taken cyclical hormone birth control or hormone replacement within 8 weeks of Visit 3. e. You have chronic heart failure, uncontrolled irregular heart beats or a history of heart disease. The study doctor or staff will discuss this with you. f. You have diabetes and are taking lipid lowering medication called statins. g. You have a history of cholelithiasis (gallbladder problems) and you have not had your gallbladder removed. h. You have an active liver disease. i. You are HIV positive. j. You have a history of cancer with in the past 5 years (except for skin cancer that has been successfully treated). k. You have taken any investigational drug within 30 days of visit 1. l. You have a history of drug or alcohol abuse with in the past 5 years m. You are not willing to stop drinking large amounts of grapefruit juice (more than a quart) a day. n. You have a know allergy or history of side effects to medicines similar to the drugs used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Low density lipoprotein cholesterol [LDL-C] lowering efficacy of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to fenofibrate 160 mg. ;Secondary Objective: a. Lipid and lipoprotein altering effects (total cholesterol [Total-C], LDL-C, triglyceride [TG], non-high density lipoprotein cholesterol [non-HDL-C], high density lipoprotein cholesterol [HDL-C], very low density lipoprotein cholesterol [VLDL-C], very low density lipoprotein triglyceride [VLDL-TG], and apolipoprotein [apo] B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to ezetimibe/simvastatin 10/20 mg. b. Lipid and lipoprotein altering effects (Total-C, TG, non-HDL-C, HDL-C, VLDL-C, VLDL-TG, apo B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to fenofibrate 160 mg. c. Lipid and lipoprotein altering effects (Total-C, LDL-C, TG, non-HDL-C, HDL-C, VLDL-C, VLDL-TG, apo B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to placebo.;Primary end point(s): The primary efficacy variable is the percent change from baseline in LDL-C to endpoint after 12 weeks of treatment. | — |
Countries
Hungary, Spain, United Kingdom
Outcome results
None listed