Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01445873
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2011-09-30
Brief Title:
Pilot Chart Review Study Of Sitaxentan Sodium Thelin In Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
NON-INTERVENTIONAL NI DRUG STUDY PROTOCOL THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN SITAXSENTAN IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION PAH
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium Thelin in real-world settings to pilot test these methods at three study centers in Europe and to refine and finalize research methods and corresponding materials for possible use in a follow-on full-scale examination of the effectiveness of sitaxentan sodium Thelin in real-world settings
Detailed Description:
At each centre approximately 12-15 Pulmonary Arterial Hypertension PAH consecutive patients who have received Thelin and who meet all other study entry criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None