| Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety |
| A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
|
- Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily
- Drug: Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
|
|
|
| Not Provided |
| |
| Terminated |
| 3 |
| January 2011 |
| January 2011 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 16 Years to 80 Years (Child, Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Romania, Ukraine, United States |
| Argentina, Bulgaria, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, India, Mexico, Peru, Philippines, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Thailand |
| |
| NCT00796510 |
| B1321002 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| April 2011 |
