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Bosentan in Digital Ulcers

NCT00319696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-02-04

Study results available
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Summary

The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

Conditions

  • Digital Ulcers

Interventions

DRUG

Bosentan 62.5 mg

Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)

DRUG

Bosentan 125 mg

Bosentan 125-mg oral tablets administered b.i.d. (target dose)

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-08
Primary Completion
2009-01-22
Completion
2009-01-22

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319696 on ClinicalTrials.gov