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
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension, Pulmonary Hypertension
In brief
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.
Key facts
- Study ID
- NCT00796666
- Run by
- Pfizer
- People needed
- 131
- Starts
- 2009-05-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2015-03-24
Who can join
Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Fountain Valley, California, United States
- Pfizer Investigational Site — Gainesville, Florida, United States
- Pfizer Investigational Site — Weston, Florida, United States
- Pfizer Investigational Site — Boston, Massachusetts, United States
- Pfizer Investigational Site — Omaha, Nebraska, United States
- Pfizer Investigational Site — Chapel Hill, North Carolina, United States
- Pfizer Investigational Site — Cincinnati, Ohio, United States
- Pfizer Investigational Site — Cleveland, Ohio, United States
- Pfizer Investigational Site — Providence, Rhode Island, United States
- Pfizer Investigational Site — Houston, Texas, United States
- Pfizer Investigational Site — San Antonio, Texas, United States
- Pfizer Investigational Site — Milwaukee, Wisconsin, United States
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Sofia, Bulgaria
- Pfizer Investigational Site — Temuco, Chile
- Pfizer Investigational Site — Changsha, Hunan, China
- Pfizer Investigational Site — Beijing, China
- Pfizer Investigational Site — Shanghai, China
- Pfizer Investigational Site — Shanghai, China
- Pfizer Investigational Site — Bogotá, Cundinamarca, Colombia
- Pfizer Investigational Site — Prague, Czechia
- Pfizer Investigational Site — Hyderabad, Andhra Pradesh, India
Full record on ClinicalTrials.gov
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