Status:
TERMINATED
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief 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 ar...
Eligibility Criteria
Inclusion
- Previously enrolled in B1321001 for at least 4 weeks.
- Previously enrolled in B1321003, discontinued from the study.
- Completed the B1321003 study as planned.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00796510
Start Date
July 1 2010
End Date
January 1 2011
Last Update
October 25 2018
Active Locations (3)
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1
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
2
Pfizer Investigational Site
Cluj-Napoca, Romania, 400 001
3
Pfizer Investigational Site
Kyiv, Ukraine