Clinical trial NCT01609140: A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Keywords: Hyperlipidemia
Dyslipidemia
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change from baseline in LDL-c concentration
timeFrame: at Day 169
Secondary outcomes:
measure: Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm
timeFrame: over the 24 week treatment period
measure: 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
timeFrame: up to Day 169
measure: Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm
timeFrame: at Day 169 and over the 24 week treatment period
measure: Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints
timeFrame: at all other designated timepoints
measure: 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
timeFrame: at Day 169 and over the 24 week treatment period
Other outcomes:
Locations:
city: Goodyear
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Ponte Verde
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: St. Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Springdale
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Bristol
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Boerne
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Wenatchee
country: United States
state: Washington
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Sarnia
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Woodstock
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte-foy
country: Canada
state: Quebec
city: St-jerome
country: Canada
state: Quebec
city: Trois-Rivières
country: Canada
state: Quebec
city: Hodonin
country: Czech Republic
city: Jičícin
country: Czech Republic
city: Marianske Lazne
country: Czech Republic
city: Ostrava - Poruba
country: Czech Republic
city: Rakovník
country: Czech Republic
city: Berlin
country: Germany
city: Köln
country: Germany
city: Komarom
country: Hungary
city: Nagykanizsa
country: Hungary
city: Nyíregyháza
country: Hungary
city: Sopron
country: Hungary
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Nelson
country: New Zealand
city: Tauranga
country: New Zealand
city: Elverum
country: Norway
city: Hamar
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Sandnes
country: Norway
city: Bardejov
country: Slovakia
city: Bratislava
country: Slovakia
city: Presov
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Pretoria
country: South Africa
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Baruch A, Mosesova S, Davis JD, Budha N, Vilimovskij A, Kahn R, Peng K, Cowan KJ, Harris LP, Gelzleichter T, Lehrer J, Davis JC Jr, Tingley WG. Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study). Am J Cardiol. 2017 May 15;119(10):1576-1583. doi: 10.1016/j.amjcard.2017.02.020. Epub 2017 Mar 1.