A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
NCT ID: NCT01258907
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
147 participants
INTERVENTIONAL
2010-03-31
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
MLDL1278A
Single intravenous dose
statin, stable dose
Repeating oral dose
B
MLDL1278A
Repeating intravenous dose
statin, stable dose
Repeating oral dose
C
placebo
Repeating intravenous dose
statin, stable dose
Repeating oral dose
Interventions
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MLDL1278A
Single intravenous dose
MLDL1278A
Repeating intravenous dose
placebo
Repeating intravenous dose
statin, stable dose
Repeating oral dose
Eligibility Criteria
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Inclusion Criteria
* Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
* Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
* For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study
Exclusion Criteria
* Pregnant, planning to become pregnant during the study, or breastfeeding
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started \< 3 months prior to study entry
* Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
* Impaired renal function
* History of malignancy within 2 years prior to screening
* Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
* Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Exposure to substantial radiation within 12 months prior to screening
35 Years
80 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua Lehrer-Graiwer, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Torrance, California, United States
Colorado Springs, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Haverhill, Massachusetts, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Newington, New Hampshire, United States
New York, New York, United States
New York, New York, United States
North Massapequa, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Houston, Texas, United States
Houston, Texas, United States
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Countries
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Other Identifiers
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GC01314
Identifier Type: OTHER
Identifier Source: secondary_id
LDL4758g
Identifier Type: -
Identifier Source: org_study_id