Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

Stopped early · Phase 3

Conditions studied: Pulmonary Arterial Hypertension, Pulmonary Hypertension

In brief

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 arterial hypertension (PAH) therapy is these two oral drugs administered in combination.

Key facts

Study ID

NCT00796510

Run by

Pfizer

People needed

3

Starts

2010-07-01

Expected to finish

2011-01-01

Last updated by the study team

2018-10-25

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously enrolled in B1321001 for at least 4 weeks.
• Previously enrolled in B1321003, discontinued from the study.
• Completed the B1321003 study as planned.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Fountain Valley, California, United States
• Pfizer Investigational Site — Cluj-Napoca, Romania
• Pfizer Investigational Site — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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