A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF THE SAFETY AND EFFICACY OF MPSK3169A IN PATIENTS WITH CORONARY HEART DISEASE OR HIGH RISK OF CORONARY HEART DISEASE

• Conditions: Coronary Heart Disease or High Risk of Coronary Heart Disease; MedDRA version: 14.1Level: LLTClassification code 10068617Term: Coronary heart diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000191-41-SK
• Lead Sponsor: GENENTECH, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-11
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• 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 =45y for men or =55y 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
• 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
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 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified