drugset / Trial / NCT00498615

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

NCT00498615

Phase 3 Completed 17 enrolled Johns Hopkins University
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2007-04
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasudil Small molecule 40 mg Oral
Subject Fasudil Small molecule 80 mg Oral