Primary Hyperlipidermia MedDRA version: 8 Level: LLT Classification code 10016205
Conditions
Interventions
Trade Name: Inegy
Product Name: Inegy
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligram(s)
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: High-risk ACS NSTE-ACS & STEMI subjects meeting the following conditions: 1. NSTE-ACS subjects meeting the following definition: a. Clinically stable NSTE-ACS subjects participating in EARLY ACS Study (P03684) that do not go on to have CABG will be eligible if enrolled within 10 days of their hospitalization. b. Clinically stable NSTE-ACS subjects not participating in EARLY ACS study who meet the following criteria will be eligible to enroll within 10 days of their hospitalization: Experience symptoms of cardiac ischemia at rest lasting at least 10 min within 24 hrs of hospitalization, at least 50yrs of age, and have 1 of the following: ECG changes in at least 2 contiguous leads characterized by either ST depression or transient ST elevation, elevation in cardiac enzymes, DM, History of MI, History of PAD, History of CVD, History of CABG at least 3 yrs prior,or multivessel documented CAD. 2. Clinically stable STEMI subjects maybe enrolled within 10 days of their hospitalization if they meet the following criteria: Experience symptoms of cardiac ischemia at rest with at least one episode lasting at least 30 minutes in conjunction with hospitalization and have ECG changes in at least 2 contiguous leads characterized by ST elevation or Qwaves or LBBB, have elevation in cardiac enzymes and the presences of anterior infarction or at least 50yrs of age. 3. LDL-C criteria: Statin naive subjects LDL-C must be at least 50 and less than or equal to 125 mg/dl, Subjects on statin LDL-C must be at least 50 and less than or equal to 100 mg/dl. 4. Fasting Plasma Triglyceride must be less than or equal to 350 mg/dl. 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. Subject who is clinically unstable. A subject is considered clinically unstable if he/she displays any of the following spontaneous events for 24 hours prior to Screening-Randomization: a. Hemodynamic events: Hypotension, Pulmonary edema/CHF, Acute mitral regurgitation, Acute ventricular septal defect. b. Ischemic events: stroke, recurrent sx of cardiac ischemica. c Arrhythmic events: Ventricular fibrillation, Sustained ventricular tachycardia, complete heart block, High grade second degree heart block 2. Subject requires the following concomitant medications: cyclosporine, diltiazem, danazol, amiodarone, verapamil, niacin, fibrates as concomitant medication or any of the potent CYP3A4 inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin and Telithromycin, HIV protease inhibitors, nedazodone 3. Pregnant or lactating woman, or intenting to become pregnant 4. Active liver disease or persistent unexplained serum transaminase elevation 5. History of alcohol or drug abuse, 6. History of intolerance or hypersensitivity to statin or ezetimibe 7. Discontinuation of existing lipid lowering regimen poses a risk to the subject 8. Subject is receiving statin therapy with an LDL-C lowering potency greater than simvastatin 40mg 9. Prior enrollment in this current study under Protocol P04103
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet) compared with Simvastatin 40mg in stablilized acute coronary syndrome (ACS) subjects. Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and non-fatal stroke. Major coronary events include non-fatal MI, documented unstable angina that requires admission into a hospital and all coronary revascularization with either PCI or CABG occuring at least 30 days after randomization. Only revasculatiztion events that occur after the first 30 days of treatment will be considered as Clinical Endpoint events, in order to focus on events that can be expected to be affected by treatment and are unrelated to the initial ACS event.; Secondary Objective: a. Evaluate the clinical benefit of Ezetimibe/Simvastatin Combination compared to Simvastatin on the occurance of the composite endpoint of death due to all causes, major coronary events and non-fatal stroke. b. Evaluate the clinical benefit of Ezetimibe/Simvastatin Combination compared to Simvastatin on the occurance of the composite endpoint of death due to coronary heart disease, non fatal MI, and urgent coronary revascularization with either PCI or CABG occurring at least 30 days after randomization. c. Evaluate the clinical benefit of Ezetimibe/Simvastatin Combination compared to Simvastatin on the occurance of the composite endpoint of CV death, non fatal MI, Unstable angna requiring hospitalization, all and revascularization at least 30 days after randomization and Non-fatal stroke ;Primary end point(s): The primary efficacy endpoint will be the time from randomization until the first occurrence of one of the following: CV death, major coronary event (non-fatal MI, documented unstable angina that requires admission into a hospital, all coronary revascularization with eith | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Italy, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed