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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Drug: Sitaxsentan; Drug: Sitaxsentan and Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796510

B1321002

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Sitaxsentan

Experimental group

Description:

Monotherapy arm

Treatment:

Drug: Sitaxsentan

Sitaxsentan and Sildenafil

Experimental group

Description:

Combination treatment

Treatment:

Drug: Sitaxsentan and Sildenafil