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NCT02601560 · ClinicalTrials.gov registry record · Phase 2
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
A Phase 2 study of Coronary Artery Disease, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 8
- Study locations
NCT02601560: Completed Phase 2 study of Coronary Artery Disease, sponsored by MedImmune.
NCT02601560 is a Phase 2 study of Coronary Artery Disease that has completed, run by MedImmune. The registered enrollment target is 48 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601560, a Phase 2 study of Coronary Artery Disease, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study dr
Conditions Studied
Interventions
- BIOLOGICAL MEDI6012
- BIOLOGICAL Placebo SC
- BIOLOGICAL Placebo IV
Study Locations (8)
Florida
- Research Site - Jacksonville
- Research Site - Port Orange
North Carolina
- Research Site - Durham
- Research Site - Raleigh
Alabama
- Research Site - Anniston
Ohio
- Research Site - Cincinnati
Texas
- Research Site - San Antonio
Virginia
- Research Site - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-12-03 |
| Est. Completion | 2016-11-03 |
| Phase | Phase 2 |
What the finished NCT02601560 record still lists
NCT02601560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 3 interventions - of which MEDI6012 is the first listed.
NCT02601560 lists 8 locations in 6 states (Florida, North Carolina, Alabama).
Frequently Asked Questions
What is clinical trial NCT02601560 about?
NCT02601560 is a clinical study titled "To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease". This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
What is the current status of trial NCT02601560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2015-12-03. Estimated completion is 2016-11-03.
What conditions does trial NCT02601560 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT02601560?
The interventions under investigation include: MEDI6012 (BIOLOGICAL), Placebo SC (BIOLOGICAL), Placebo IV (BIOLOGICAL).
Who is sponsoring clinical trial NCT02601560?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02601560 being conducted?
This trial has 8 study locations across Alabama, Florida, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02601560's enrollment target sits among peer trials
48 182nd of 219 higher than 36 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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