Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01365585
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2011-06-01
Brief Title:
Evaluate The Clinical Effectiveness Safety And Tolerability Of Sildenafil Used In Doses 20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
Evaluate The Clinical Effectiveness Safety And Tolerability Of Sildenafil Used In Doses 20mg TID For The Treatment Of Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-01
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 objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate Revatio for the treatment of pulmonary arterial hypertension PAH The primary objective is to assess effectiveness and safety of sildenafil at doses 20mg three times daily for the treatment of PAH
Detailed Description:
The study design proposed is a retrospective chart review going back five years 01 April 2006 estimate from the time of study initiation 31 March 2011 estimate Within this five-year period study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months The patient has to be taking sildenafil at doses 20mg tid for the treatment of PAH
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