| Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil |
| A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639) |
| As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
|
- Drug: Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
- 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 |
| 131 |
| March 2011 |
| March 2011 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.
Exclusion Criteria:
- Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), 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 |
| Argentina, Bulgaria, Chile, China, Colombia, Czech Republic, India, Malaysia, Mexico, Peru, Romania, Russian Federation, Serbia, South Africa, Thailand, Turkey, Ukraine, United States |
| Costa Rica, Dominican Republic, Philippines, Saudi Arabia, Slovakia |
| |
| NCT00796666 |
| B1321003 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2015 |
