At a glance
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A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers
In Brief
A Phase 2 clinical trial evaluating Riociguat and Placebo for Scleroderma and Digital Ulcers. Completed, enrolled 17 participants across 5 sites.
Detailed Summary
The primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers
Study Details
Timeline
Interventions
riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)
Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;