Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom - Bosentan1
Phase 1
Active, not recruiting
- Conditions
- secondary Raynauds Syndrome
- Registration Number
- EUCTR2004-002686-21-AT
- Lead Sponsor
- Dept of Dermatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: efficacy of bosentan in secondary raynauds syndrome;Secondary Objective: ;Primary end point(s): Raynauds symptom score<br>Oszillography<br>quality of life
- Secondary Outcome Measures
Name Time Method