A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
The purpose of this study is to evaluate the safety and cholesterol lowering effects of
 MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a
 high risk of cardiovascular events and LDL-c levels well above goal.
Inclusion Criteria:

 -  Use of a standard-of-care statin at a stable dose, or intolerance of statins, without
 use of other lipid modifying therapies

 -  Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above

 And at least one of the following:

 -  Coronary heart disease (CHD) with a history of myocardial infarction (MI),
 percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG),
 or prior coronary angiography demonstrating coronary atherosclerosis

 -  A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic
 kidney disease, prior stroke, carotid disease, peripheral arterial disease, or
 abdominal aortic aneurism

 -  >/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking;
 hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of
 a CV event based on risk estimation systems

 Exclusion Criteria:

 -  Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection
 fraction </= 35%

 -  Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG,
 PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac
 arrhythmia (other than atrial fibrillation or flutter), or initiation of renal
 replacement therapy (dialysis)

 -  Fasting serum triglyceride level >/= 400 mg/dL

 -  Homozygous familial hypercholesterolemia

 -  Poorly controlled diabetes mellitus, hypertension or thyroid disease

 -  Liver or muscle disease, including abnormal test results at screening

 -  Pregnant or lactating

 The above list is not intended to contain all factors relevant to a patient's eligibility
 for the study.