An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 490

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

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 < 3 months, contact the Headquarters Clinical Monitor for a case-by-case evaluation.)
c.Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
d.Congestive heart failure defined by NYHA Class III or IV.
e.Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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