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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609140
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 31, 2012
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
Absolute change from baseline in LDL-c concentration [ Time Frame: at Day 169 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01609140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
  • Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm [ Time Frame: over the 24 week treatment period ]
  • 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 [ Time Frame: up to Day 169 ]
  • Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm [ Time Frame: at Day 169 and over the 24 week treatment period ]
  • Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints [ Time Frame: at all other designated timepoints ]
  • 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 [ Time Frame: at Day 169 and over the 24 week treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • Drug: MPSK3169A
    Dose regimen A, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen E, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen D, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen C, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen B, repeating subcutaneous injections every 4 weeks
  • Drug: Placebo
    Repeating subcutaneous injections of placebo every 4 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: MPSK3169A
  • Experimental: B
    Intervention: Drug: MPSK3169A
  • Experimental: C
    Intervention: Drug: MPSK3169A
  • Experimental: D
    Intervention: Drug: MPSK3169A
  • Experimental: E
    Intervention: Drug: MPSK3169A
  • Placebo Comparator: F
    Intervention: Drug: Placebo
Publications * 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. Erratum in: Am J Cardiol. 2018 Feb 12;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2012)
248
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2012)
224
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   Germany,   Hungary,   New Zealand,   Norway,   Slovakia,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01609140
Other Study ID Numbers  ICMJE GC28210
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP