CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17 enrolled
Drug / intervention
Fasudildrug
Likely dose
Fasudil 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00498615
NCT00498615Phase 3Completed

Efficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

Johns Hopkins University·interventional·Posted Jul 10, 2007·Updated Nov 4, 2014

In Brief

A Phase 3 clinical trial evaluating Fasudil for Raynaud and Scleroderma. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRaynaud, Scleroderma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2007
Enrollment StartApr 1, 2007
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 19.0 years ago

Interventions

Fasudildrug

Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible sequences. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.