Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000632-82-IT

Enrollment

180

Registered

2007-03-15

Start date

2005-04-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis Level: PT Classification code 10059084

Interventions

Trade Name: TRACLEER*56CPR RIV 125MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: To collect long-term efficacy, tolerability and safety data of bosentan in systemic sclerosis SSc patients suffering from ischemic digital ulcers DU .;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026