Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom - Bosentan1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002686-21-AT

Enrollment

Registered

2005-01-18

Start date

2005-02-22

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

secondary Raynauds Syndrome

Interventions

Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adult patients with secondary Raynauds syndrome Are the trial subjects under 18? no 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: primary Raynuads syndrome pulmonal hypertension WHO III IV parenteral prostanoids Treatment of PDE with Sildenafil pregnancy, breast feeding pretreatment with bosentan AST or ALT > §ULN

Design outcomes

Primary

Measure	Time frame
Main Objective: efficacy of bosentan in secondary raynauds syndrome;Secondary Objective: ;Primary end point(s): Raynauds symptom score Oszillography quality of life	—

Countries

Austria

Outcome results

None listed

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