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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609140
• Other study ID #: GC28210
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2012
• Last updated: November 1, 2016
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• MPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks
• MPSK3169A
Dose regimen E, repeating subcutaneous injections every 4 weeks
• MPSK3169A
Dose regimen D, repeating subcutaneous injections every 4 weeks
• MPSK3169A
Dose regimen C, repeating subcutaneous injections every 4 weeks
• MPSK3169A
Dose regimen B, repeating subcutaneous injections every 4 weeks
• Placebo
Repeating subcutaneous injections of placebo every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  Hungary,  New Zealand,  Norway,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in LDL-c concentration		at Day 169	No
Secondary	Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm		over the 24 week treatment period	No
Secondary	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		up to Day 169	No
Secondary	Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm		at Day 169 and over the 24 week treatment period	No
Secondary	Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints		at all other designated timepoints	No
Secondary	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		at Day 169 and over the 24 week treatment period	No