hypercholesterolemia MedDRA version: 14.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: INEGY
Product Code: MK0653a
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe Simvastatin
Concentration unit: mg milligram(s)
Concentration number: 10-40
Pharmaceutical Form:
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria b. Patient has taken a stable daily dose of one of the following medications for the past 3 months: • atorvastatin 10 mg, 20 mg, or 40 mg, or; • pravastatin 10 mg or 20 mg, or; • simvastatin 10 mg, 20 mg, or 40 mg, or; • fluvastatin 20 mg, 40 mg or; • lovastatin 10mg, 20mg or; • rosuvastatin 10mg, 20mg Criteria c. Patient is hospitalized for investigation of a coronary event: • unstable angina pectoris with electrocardiogram changes, or; • increased troponin levels following myocardial infarction, or; • changes in creatine kinase-MB (CKMB) following myocardial infarction. 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: a. Patients who are pregnant or lactating. b. Patients who have been treated with any other investigational drug within 3 months of Visit 1. (If 160 mm Hg or diastolic > 100 mm Hg at Visit 1. f. Type I or Type II diabetes mellitus that is poorly controlled (HbA1c > 9.0%) or newly diagnosed (within 3 months). g. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidemia) or secondary hypercholesterolemia due to hypothyroidism, (TSH> ULN) at Visit 1. Note: Patients with a history of hypothyroidism, who is on stable therapy of thyroid hormone replacement for at least 6 weeks, are eligible for enrollment. h. Impaired renal function [creatinine ? 177 ?mol/L (? 2.0 mg/dL)] or nephrotic syndrome at Visit 1. i. Disorder of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation. j. Patient who is known HIV positive. k. Cancer within the past 5 years (except for an anticipated clinically cured conditions with normal life expectancy). l. History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. Prohibited Concomitant Therapies m. Medications that are potent inhibitors of CYP3A4, including cyclosporine or danazol, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, and protease inhibitors, verapamil, diltiazem, and amiodarone. Patients that consume more than one quart of grapefruit juice per day. n. Lipid-lowering agents that include fish oils, Cholestin, bile-acid sequestrants, or niacin (>200 mg/day) taken within 6 weeks and fibrates within 8 weeks prior to randomization at Visit 1. o. Oral corticosteroids (unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : In patients taking a statin and admitted to a hospital for investigation of a coronary event, to evaluate the efficacy of switching to ezetimibe/simvastatin (10mg/40mg) on discharge compared to doucling the statin dose as added by the LDL-C values achieved after 12 weeks of treatment.;Secondary Objective: Secondary objectives : 1) to determine th effect of ezetimibe/simvastatin (10mg/40mg) compared to doubling the statin dose on total cholesterol 2) to determine the effect of ezetimibe/simvastatin (10mg/40mg) compared to doubling the statin dose on triglycerides, high-density lipoprotein cholesterol (HDL-C), and non-HDL-C, LDL-C/HDC-C ratio, TC/HDL-C ratio and apolipoprotein (apo) B. 3)to evaluate the safety of ezetimibe/simvastatin (10mg/40mg) versus doubling the statin dose. ;Primary end point(s): The primary efficacy variable is the actual LDL-C follow-up value after 12 weeks of treatment. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed