NCT00080457

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: Encysive Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons of safety and efficacy.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	sitaxsentan sodium

Timeline

• Start date: 2003-05-01
• Completion: 2005-01-01
• First posted: 2004-04-05
• Last updated: 2007-11-09

Locations

1 site across 1 country: United States