drugset / Trial / NCT00796510
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
Non-randomizedParallel-groupOpen-labelTreatment
Summary
As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-01
- Completion
- 2011-01
Outcome
Outcome not reported
Stopped: “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sildenafil | Unknown | 20 mg | Oral |
| Subject | Sitaxentan | Small molecule | 100 mg | Oral |