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NCT02187172 · ClinicalTrials.gov registry record · Phase 4
Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)
A Phase 4 study of Cardiovascular Disease and Psoriasis, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT02187172: Completed Phase 4 study of Cardiovascular Disease and Psoriasis, sponsored by University of Pennsylvania.
NCT02187172 is a Phase 4 study of Cardiovascular Disease and Psoriasis that has completed, run by University of Pennsylvania. The registered enrollment target is 43 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187172, a Phase 4 study of Cardiovascular Disease and Psoriasis, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis. This study will look for systemic vascular inflammation in study participants with a test called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in blood samples, including markers of high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation. The study will also examine the effects of ustekinumab compared to placebo on psoriasis activity, severity and safety.
Primary Outcome
Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ustekinumab
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-07 |
| Est. Completion | 2018-09-11 |
| Phase | Phase 4 |
What the finished NCT02187172 record still lists
NCT02187172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02187172 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02187172 about?
NCT02187172 is a clinical study titled "Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)". The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis. This study will look for systemic vascular inflammation in study participa...
What is the current status of trial NCT02187172?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2014-07. Estimated completion is 2018-09-11.
What conditions does trial NCT02187172 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Psoriasis.
What interventions are being tested in trial NCT02187172?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT02187172?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02187172 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02187172's enrollment target sits among peer trials
43 113th of 137 higher than 23 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular 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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