Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension

Inclusion Criteria

• •Have a current diagnosis of symptomatic PAH classified by one of the following:
• •1. primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH);
• •2. PAH associated with connective tissue diseases;
• •3. PAH associated with one of the following congenital heart defects:
• •1. repaired ASD, VSD or PDA greater than one year post-operative
• •2. un-repaired secundum ASD (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)
• •World Health Organization (WHO) functional class II, III, IV
• •Greater than 12 and less than 75 years of age
• •Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)
• •Have a cardiac catheterization within 6 months before study entry that shows the following values:
• •1. mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest),
• •2. pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than 15 mmHg, and
• •3. pulmonary vascular resistance (PVR) greater than 3 mmHg/L/min.