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NCT01121458 · ClinicalTrials.gov registry record · Phase 4

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

A Phase 4 study, sponsored by North Texas Veterans Healthcare System.

Completed
Registry status
Phase 4
Development phase
12
Enrollment target

NCT01121458: Completed Phase 4 study, sponsored by North Texas Veterans Healthcare System.

NCT01121458 is a Phase 4 study that has completed, run by North Texas Veterans Healthcare System. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01121458, a Phase 4 study, has completed, sponsored by North Texas Veterans Healthcare System.

COMPLETED
Registry status
Phase 4
Development phase
12 participants
Enrollment target

Study Summary

Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (PA) rises above normal levels and may become life threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the time it is accurately diagnosed. PAH has been historically chronic and incurable with a poor survival rate. However, new treatments are available which have significantly improved prognosis. Right-heart catheterization (RHC) is the most accurate and useful test for PAH, and the only test that directly measures the pressure inside the PA. It is performed in all patients at least once, to get a definitive diagnosis of PAH. The most commonly used medication for this purpose is intravenous nitroprusside, however this medication in about 25-30% of patients is not well tolerated as it cause fast heart rates, which is not well tolerated by patients with pulmonary hypertension and/or heart failure. The CARVE study assesses the effect of Clevidipine, an ultra-short acting vasoselective calcium antagonist, on pulmonary vascular resistance (PVR) and its utility for pulmonary vasoreactivity testing during right heart catheterization (RHC) of patients with pulmonary hypertension (PAH).

Interventions

  • DRUG Clevidipine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-09
Est. Completion 2013-04
Phase Phase 4

What the finished NCT01121458 record still lists

NCT01121458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

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

NCT01121458 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01121458 about?

NCT01121458 is a clinical study titled "Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed". Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (PA) rises above normal levels and may become life threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the time it is accurately diagnosed...

What is the current status of trial NCT01121458?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2009-09. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01121458?

The interventions under investigation include: Clevidipine (DRUG).

Who is sponsoring clinical trial NCT01121458?

This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01121458's enrollment target sits among peer trials

12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01121458, the US trial registry maintained by the National Library of Medicine. NCT01121458 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.