IRB Number:

08-003125

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

The main purpose of this clinical research is to find out if this investigational medication (ACT-064992) can delay the time to clinical worsening of your condition. In other words, this investigational medication might improve your health by:

-- Improving the symptoms you experience from your disease
-- Increasing your ability to exercise
-- Improving your pulmonary artery pressure
-- Preventing your disease from worsening
-- Improving your quality of life

Who is Eligible to Participate in the Study?

Male or Female from 18 years old and above.

What is Involved With this Study?

If you agree to be in the study, you will be asked to participate in the following:

During the study you will have at least 5 visits, and possibly up to 13 visits, to the hospital/clinic. You will visit the hospital/clinic for two qualifying visits (screening and randomization), which may be combined in some cases, and then again after three months, six months and every six months until the end of study.

Both as part of the study and as part of your routine medical care, certain medical procedures and tests will be performed at each visit.

How long will the Study run?

The research takes place over 48 months for the first patient enrolled or at least 18 months for the last patient enrolled. During that time, it will be necessary for you to come to the clinic for visits. In total you will be asked to come at least 5 times, and possibly up to 13 times, to the clinic for your clinical evaluation.

Who can I Contact for Additional Information on this Trial?

Pamela Long
(904) 953-7719

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 07/27/2009