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SR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil

IRB Number:

08-006186

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This is a clinical research study designed to evaluate the safety and effectiveness of sitaxsentan 100 mg tablet (given by mouth) compared to placebo (a tablet that does not contain any medicine) for the treatment of pulmonary arterial hypertension.

Who is Eligible to Participate in the Study?

Current diagnosis of symptomatic PAH classified by one of the following: IPAH, PPH, FPAH or PAH associated with connective tissue diseases. Has WHO functional class III symptoms.

Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan, and ambrisentan is prohibited.

Other Inclusion/Exclusion apply

Minimum Age:

18

Maximum Age:

80

What is Involved With this Study?

Screening Visits Procedures, Test and Evaluations

How long will the Study run?

To June 2010

Who can I Contact for Additional Information on this Trial?

Pamela Long, RN CCRP
long.pamela@mayo.edu
904-953-7719

What is/are the Locations of this Clinical Trial?

  • Jacksonville, FL

Last updated: 08/31/2009