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NCT01270945 · ClinicalTrials.gov registry record · Phase 2

Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

A Phase 2 study of Patients Undergoing Repeat Peripheral Artery Revascularization, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target
8
Study locations

NCT01270945: Completed Phase 2 study of Patients Undergoing Repeat Peripheral Artery Revascularization, sponsored by Janssen Research & Development.

NCT01270945 is a Phase 2 study of Patients Undergoing Repeat Peripheral Artery Revascularization that has completed, run by Janssen Research & Development. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01270945, a Phase 2 study of Patients Undergoing Repeat Peripheral Artery Revascularization, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target
8
Study locations

Study Summary

The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

Primary Outcome

adverse events, vitals signs, physical examination results and clinical laboratory values

Interventions

  • PROCEDURE Standard of Care
  • DRUG CV-18C3

Study Locations (8)

Florida

  • JFK Medical Center - Atlantis
  • River City Clinical Research - Jacksonville
  • Jacksonville Center for Clinical Research - Jacksonville
  • Mediquest Research Group - Ocala

California

  • Sutter Heart & Vascular Institute - Sacramento

Georgia

  • John D. Archbold Memorial Hospital - Thomasville

Ohio

  • Univeristy of Cincinnati University Hospital - Cincinnati

Texas

  • Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2011-06-30
Est. Completion 2014-04-30
Phase Phase 2
Janssen Research & Development

593 total trials

What the finished NCT01270945 record still lists

NCT01270945 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Patients Undergoing Repeat Peripheral Artery Revascularization appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT01270945 lists 8 locations in 5 states (Florida, California, Georgia).

Frequently Asked Questions

What is clinical trial NCT01270945 about?

NCT01270945 is a clinical study titled "Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.". The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

What is the current status of trial NCT01270945?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2011-06-30. Estimated completion is 2014-04-30.

What conditions does trial NCT01270945 study?

This clinical trial studies the following conditions: Patients Undergoing Repeat Peripheral Artery Revascularization.

What interventions are being tested in trial NCT01270945?

The interventions under investigation include: Standard of Care (PROCEDURE), CV-18C3 (DRUG).

Who is sponsoring clinical trial NCT01270945?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01270945 being conducted?

This trial has 8 study locations across California, Florida, Georgia, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01270945's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01270945, the US trial registry maintained by the National Library of Medicine. NCT01270945 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.