A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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.

Key facts

Study ID

NCT01609140

Run by

Genentech, Inc.

People needed

248

Starts

2012-05-01

Expected to finish

2013-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Carmichael, California, United States
• Study site — Spring Valley, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Wildomar, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Ponte Verde, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Auburn, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Bethesda, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Fargo, North Dakota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Springdale, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Greer, South Carolina, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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