A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sitaxsentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811018

FPH03

B1321007

Details and patient eligibility

About

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Full description

Open-label extension

Enrollment: 1,192 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
• Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion criteria

• Has portal hypertension or chronic liver disease.
• Has history of left sided heart disease or significant cardiac disease.

Trial design

1,192 participants in 1 patient group

Sitaxsentan

Experimental group

Description:

Sitaxsentan

Treatment:

Drug: Sitaxsentan