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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.
Interventions
- DRUG Fasudil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00498615 record still lists
NCT00498615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Fasudil is the first listed.
NCT00498615 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00498615's enrollment target sits among peer trials
17 1971st of 2000 higher than 27 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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