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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Encysive Pharmaceuticals
• Treatments: Sitaxsentan

Criteria

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.

Exclusion Criteria:

• Portal hypertension or chronic liver disease

• ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit

• Contraindication to treatment with an endothelin receptor antagonist

• Recent history of abusing alcohol or illicit drugs

• Chronic renal insufficiency

• Pregnant or breastfeeding

• Atrial septostomy within 30 days before study entry

• Previous failure on bosentan because of safety concerns of the lack of clinical response