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NCT01645111 · ClinicalTrials.gov registry record · Phase 2

An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion

A Phase 2 study, sponsored by Nationwide Children's Hospital.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT01645111: Completed Phase 2 study, sponsored by Nationwide Children's Hospital.

NCT01645111 is a Phase 2 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01645111, a Phase 2 study, has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

Primary Outcome

The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg

Interventions

  • DRUG Clevidipine

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-06
Est. Completion 2013-12
Phase Phase 2
Nationwide Children's Hospital

188 total trials

What the finished NCT01645111 record still lists

NCT01645111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 1 intervention - of which Clevidipine is the first listed.

NCT01645111 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01645111 about?

NCT01645111 is a clinical study titled "An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion". The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idi...

What is the current status of trial NCT01645111?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01645111?

The interventions under investigation include: Clevidipine (DRUG).

Who is sponsoring clinical trial NCT01645111?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01645111's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 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 NCT01645111, the US trial registry maintained by the National Library of Medicine. NCT01645111 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.