Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Endothelin Receptor Antagonists; Sildenafil Citrate; Sitaxsentan

Criteria

Inclusion Criteria:

• Previously enrolled in B1321001 for at least 4 weeks.

• Previously enrolled in B1321003, discontinued from the study.

• Completed the B1321003 study as planned.

Exclusion Criteria:

• Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.