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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258907
First Posted: December 13, 2010
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.
Collaborator:
BioInvent International AB
Information provided by (Responsible Party):
Genentech, Inc.
December 10, 2010
December 13, 2010
November 2, 2016
March 2010
July 2012   (Final data collection date for primary outcome measure)
Change in TBR as measured by FDG-PET/CT [ Time Frame: Baseline to Week 12 ]
Same as current
Complete list of historical versions of study NCT01258907 on ClinicalTrials.gov Archive Site
  • Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A [ Time Frame: Throughout study or until early discontinuation ]
  • Effects of MLDL1278A on inflammatory and metabolic biomarkers [ Time Frame: Throughout study or until early discontinuation ]
Same as current
Not Provided
Not Provided
 
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)
A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Atherosclerosis
  • Drug: MLDL1278A
    Single intravenous dose
  • Drug: MLDL1278A
    Repeating intravenous dose
  • Drug: placebo
    Repeating intravenous dose
  • Drug: statin, stable dose
    Repeating oral dose
  • Experimental: A
    Interventions:
    • Drug: MLDL1278A
    • Drug: statin, stable dose
  • Experimental: B
    Interventions:
    • Drug: MLDL1278A
    • Drug: statin, stable dose
  • Placebo Comparator: C
    Interventions:
    • Drug: placebo
    • Drug: statin, stable dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
Not Provided
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Evidence of qualifying vessel (carotid or aortic) plaque inflammation
  • 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:

  • Occurrence of a cardiovascular event < 6 months prior to screening
  • 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
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01258907
LDL4758g
GC01314 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
BioInvent International AB
Study Director: Joshua Lehrer-Graiwer, M.D. Genentech, Inc.
Genentech, Inc.
November 2016

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