OHSU

IRB #

IRB00009871

Title

A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument

Principal Investigator

Akram Khan

Study Purpose

Purpose of this study is:
1)To evaluate a questionnaire called the PAH-SYMPACT, to understand if it can measure quality of life in patients with pulmonary arterial hypertension.
2)To evaluate the validity and reliability of the questionnaire PAH-SYMPAC.
3)To find out more about the safety of the study drug for pulmonary arterial hypertension
4)To explore the effects of study drug on PAH symptoms and their impact in patients with PAH.

Medical Condition(s)

Pulmonary Arterial Hypertension

Eligibility Criteria

Men and women between ages 18-80 with symptomatic Pulmonary Arterial Hypertension

Age Range

18 - 80

Healthy Volunteers Needed

No

Duration of Participation

approximately 20 months

Minors Included

No

Contact

Nathan Kessler
Ph:503-494-9570
e-mail:kesslena@ohsu.edu

Sponsor

Actelion Pharmaceuticals US, Inc.
5000 Shoreline Court
South San Francisco, CA 94080
USA

Recruitment End

06/30/2014

Compensation Provided

Yes

Compensation

Upto $200 will be paid for travel expenses, based on expense receipts.


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