Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension, Pulmonary Hypertension

In brief

This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.

Key facts

Study ID

NCT00795639

Run by

Pfizer

People needed

183

Starts

2008-12-01

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…

• Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

You may not qualify if…

• Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.

Where it is running

• Pfizer Investigational Site — Mather, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — Englewood, Colorado, United States
• Pfizer Investigational Site — Littleton, Colorado, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Sarasota, Florida, United States
• Pfizer Investigational Site — Weston, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Olathe, Kansas, United States
• Pfizer Investigational Site — Towson, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — New Brunswick, New Jersey, United States
• Pfizer Investigational Site — Islandia, New York, United States
• Pfizer Investigational Site — Stony Brook, New York, 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 — Lancaster, Pennsylvania, United States
• Pfizer Investigational Site — Lancaster, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Providence, Rhode Island, United States
• Pfizer Investigational Site — Charleston, South Carolina, United States
• Pfizer Investigational Site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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