Status:
COMPLETED
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)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
BioInvent International AB
Conditions:
Atherosclerosis
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
Brief Summary
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 atheroscl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01258907
Start Date
March 1 2010
Last Update
November 2 2016
Active Locations (24)
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1
Torrance, California, United States, 90502
2
Colorado Springs, Colorado, United States, 80904
3
Washington D.C., District of Columbia, United States, 20010
4
Gainesville, Florida, United States, 32605