A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
NCT ID: NCT01609140
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2012-05-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
MPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks
B
MPSK3169A
Dose regimen B, repeating subcutaneous injections every 4 weeks
C
MPSK3169A
Dose regimen C, repeating subcutaneous injections every 4 weeks
D
MPSK3169A
Dose regimen D, repeating subcutaneous injections every 4 weeks
E
MPSK3169A
Dose regimen E, repeating subcutaneous injections every 4 weeks
F
Placebo
Repeating subcutaneous injections of placebo every 4 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Goodyear, Arizona, United States
Carmichael, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Wildomar, California, United States
Jacksonville, Florida, United States
Ponte Verde, Florida, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
St Louis, Missouri, United States
Rochester, New York, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Springdale, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Knoxville, Tennessee, United States
Boerne, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Wenatchee, Washington, United States
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Woodstock, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Sainte-Foy, Quebec, Canada
Trois-Rivières, Quebec, Canada
Hodonín, , Czechia
Jičícin, , Czechia
Mariánské Lázně, , Czechia
Ostrava - Poruba, , Czechia
Rakovník, , Czechia
Berlin, , Germany
Cologne, , Germany
Komárom, , Hungary
Nagykanizsa, , Hungary
Nyíregyháza, , Hungary
Sopron, , Hungary
Auckland, , New Zealand
Auckland, , New Zealand
Christchurch, , New Zealand
Nelson, , New Zealand
Tauranga, , New Zealand
Elverum, , Norway
Hamar, , Norway
Oslo, , Norway
Oslo, , Norway
Sandnes, , Norway
Bardejov, , Slovakia
Bratislava, , Slovakia
Prešov, , Slovakia
Rimavská Sobota, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
Centurion, , South Africa
Pretoria, , South Africa
Countries
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References
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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.
Other Identifiers
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GC28210
Identifier Type: -
Identifier Source: org_study_id