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
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
MedDRA version: 14.1Level: LLTClassification code 10068617Term: Coronary heart diseaseSystem Organ Class: 10007541 - Cardiac disorders

Registration Number: EUCTR2012-000191-41-HU

Lead Sponsor: GENENTECH, Inc.

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the safety of MPSK3169A on top of standard-of-care (SOC) statin in patients with an low-density lipoprotein cholesterol (LDL-c) of 90-250 mg/dL and either coronary heart disease (CHD) or a CHD risk equivalent <br>• To evaluate the ability of MPSK3169A to reduce LDL-c on top of SOC statin therapy in patients with an LDL-c of 90-250 mg/dL and either CHD or a CHD risk equivalent;Secondary Objective: The PK and PD objectives for this study are as follows:<br>• To characterize the serum concentration of MPSK3169A over time following multiple subcutaneous (SC) doses of MPSK3169A<br>• To evaluate the effect of MPSK3169A on LDL-c–related biomarkers<br>• To characterize the relationship between MPSK3169A concentration and the effect on LDL-c and LDL-c–related biomarkers;Primary end point(s): Absolute change from baseline in LDL-c concentration at Day 169;Timepoint(s) of evaluation of this end point: Day 169

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm<br>2. Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements <br>3. Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm<br>4. Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints<br>5. Percent and absolute change from baseline in total cholesterol, non–HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm;Timepoint(s) of evaluation of this end point: 1. at the nadir for that arm<br>2. up to Day 169,<br>3. at Day 169 and at the nadir for each arm<br>4. at all other designated timepoints<br>5. at Day 169 and at the nadir for each arm

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