Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483626
Status:
UNKNOWN
Last Update Posted:
2007-06-07
First Post:
2007-06-06
Brief Title:
Hemodynamic Response After Six Months of Sildenafil
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension Response to Sildenafil Treatment
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
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 purpose of this study is to determine the clinical functional and hemodynamic response after six months of sildenafil 50 mg TID in patients with pulmonary arterial hypertension
Detailed Description:
Pulmonary arterial hypertension is a chronic devastating disease There are few approval oral treatments Sildenafil a phosphodiesterase 5 inhibitors has been recently approved for patients on functional class II and III showing hemodynamic benefits after 12 weeks of treatment Long term hemodynamic evaluation after sildenafil treatment has not been evaluating in pulmonary arterial patients on functional class II to IV
The protocol has been designed to evaluate patients on functional class II to IV from baseline conditions and after 6 months of sildenafil treatment 50 mg po TID Clinical functional class functional walked distance-6 minute walking test and Hemodynamic evaluation is planned to be performed at baseline and after 6 months of treatment
The protocol has been designed to evaluate patients on functional class II to IV from baseline conditions and after 6 months of sildenafil treatment 50 mg po TID Clinical functional class functional walked distance-6 minute walking test and Hemodynamic evaluation is planned to be performed at baseline and after 6 months of treatment
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