Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00796666
Start Date
May 1 2009
End Date
March 1 2011
Last Update
March 24 2015
Active Locations (48)
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1
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
2
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
3
Pfizer Investigational Site
Weston, Florida, United States, 33331
4
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111