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NCT00093262 · ClinicalTrials.gov registry record · Phase 3

Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

A Phase 3 study, sponsored by The Medicines Company.

Completed
Registry status
Phase 3
Development phase
206
Enrollment target

NCT00093262: Completed Phase 3 study, sponsored by The Medicines Company.

NCT00093262 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00093262, a Phase 3 study, has completed, sponsored by The Medicines Company.

COMPLETED
Registry status
Phase 3
Development phase
206 participants
Enrollment target

Study Summary

The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.

Primary Outcome

The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons: * Bailout for lack of efficacy * Bailout for safety reason(s) * Bailout due to treatment failure

Interventions

  • DRUG placebo
  • DRUG clevidipine

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2003-12
Est. Completion 2004-10
Phase Phase 3
The Medicines Company

35 total trials

What the finished NCT00093262 record still lists

NCT00093262 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00093262 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00093262 about?

NCT00093262 is a clinical study titled "Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)". The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive ...

What is the current status of trial NCT00093262?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2003-12. Estimated completion is 2004-10.

What interventions are being tested in trial NCT00093262?

The interventions under investigation include: placebo (DRUG), clevidipine (DRUG).

Who is sponsoring clinical trial NCT00093262?

This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00093262's enrollment target sits among peer trials

206 1347th of 2000 higher than 651 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00093262, the US trial registry maintained by the National Library of Medicine. NCT00093262 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.