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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609140
First Posted: May 31, 2012
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease Drug: MPSK3169A Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Absolute change from baseline in LDL-c concentration [ Time Frame: at Day 169 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 248
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks
Experimental: B Drug: MPSK3169A
Dose regimen B, repeating subcutaneous injections every 4 weeks
Experimental: C Drug: MPSK3169A
Dose regimen C, repeating subcutaneous injections every 4 weeks
Experimental: D Drug: MPSK3169A
Dose regimen D, repeating subcutaneous injections every 4 weeks
Experimental: E Drug: MPSK3169A
Dose regimen E, repeating subcutaneous injections every 4 weeks
Placebo Comparator: F Drug: Placebo
Repeating subcutaneous injections of placebo every 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609140


  Show 73 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01609140     History of Changes
Other Study ID Numbers: GC28210
First Submitted: May 24, 2012
First Posted: May 31, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Genentech, Inc.:
Hyperlipidemia
Dyslipidemia

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases