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

Merck Sharp & Dohme Gesellschaft m.b.H.0 sites490 target enrollmentDecember 29, 2004

Overview

No summary available.

Registry

who.int

Start Date

December 29, 2004

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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;

•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.