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NCT00498615 · ClinicalTrials.gov registry record · Phase 3

A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

A Phase 3 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 3
Development phase
17
Enrollment target

NCT00498615: Completed Phase 3 study, sponsored by Johns Hopkins University.

NCT00498615 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00498615, a Phase 3 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 3
Development phase
17 participants
Enrollment target

Study Summary

Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. The investigators' study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.

Interventions

  • DRUG Fasudil

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2007-04
Est. Completion 2012-03
Phase Phase 3

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT00498615

The ClinicalTrials.gov registry entry for NCT00498615 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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

NCT00498615 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00498615 about?

NCT00498615 is a clinical study titled "A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon". Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often cont...

What is the current status of trial NCT00498615?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2007-04. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00498615?

The interventions under investigation include: Fasudil (DRUG).

Who is sponsoring clinical trial NCT00498615?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.