Clinical Trial: Patient Reported Outcomes in Pulmonary Arterial Hypertension

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Patient Reported Outcomes in Pulmonary Arterial Hypertension

Brief Summary: Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.

Detailed Summary: This study will use the Clinical Impact Method to develop a patient reported outcome for use in patients with pulmonary arterial hypertension Clinical personnel at the study sites will approach and discuss possible participation in Phase I and II of the study with subjects from the existing pool of patients currently receiving usual and customary care at the site.
Sponsor: Pfizer

Current Primary Outcome: The primary endpoint for the study will be a composite symptom score derived from items in the instrument. [ Time Frame: Patients in Phase 1 and 2 shall be engaged in the study for approximately one hour's time; Phase 1 will take 3 to 6 weeks, and Phase 2 will proceed until sufficient sample size is obtained (saturation); we anticipate completion by September 2013. ]

Original Primary Outcome: The primary endpoint for the study will be a composite symptom score derived from items in the instrument. [ Time Frame: Patients in Phase 1 and 2 shall be engaged in the study for approximately one hour's time; Phase 1 will take 3 to 6 weeks, and Phase 2 will proceed until sufficient sample size is obtained (saturation); we anticipate completion by September 2013. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: February 7, 2013
Date Started: July 2013
Date Completion: September 2013
Last Updated: July 31, 2013
Last Verified: July 2013