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NCT01258907 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT01258907 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 147 participants.
The verdict
NCT01258907, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study 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 atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
Interventions
- DRUG placebo
- DRUG MLDL1278A
- DRUG statin, stable dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2010-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01258907
The ClinicalTrials.gov registry entry for NCT01258907 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01258907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01258907 about?
NCT01258907 is a clinical study titled "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 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.
What is the current status of trial NCT01258907?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2010-03.
What interventions are being tested in trial NCT01258907?
The interventions under investigation include: placebo (DRUG), MLDL1278A (DRUG), statin, stable dose (DRUG).
Who is sponsoring clinical trial NCT01258907?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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