Ignite Creation Date:
2024-05-05 @ 9:30 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00902603
Status:
TERMINATED
Last Update Posted:
2015-04-10
First Post:
2009-05-13
Brief Title:
Ventavis Registry Protocol
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Registry to Prospectively Evaluate Use of Ventavis in Patients With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment and difficulty recruiting eligible patients in adequate time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPIRE
Brief Summary:
The Ventavis iloprost Registry is a multicenter observational US-based study that longitudinally follows patients with pulmonary arterial hypertension PAH who have been receiving therapy with Ventavis for at least 3 months Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis will be followed for a maximum of 2 years from the time of enrollment Data will be collected via patient interview and review of the medical record Quarterly data collection will include capture of medications and Ventavis adherence data
Detailed Description:
The Ventavis iloprost Registry is a multicenter observational US-based study that longitudinally follows patients with pulmonary arterial hypertension PAH who have been receiving therapy with Ventavis for at least 3 months Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis will be followed for a maximum of 2 years from the time of enrollment All data will be collected via patient interview andor review of the medical record as well as from I-neb downloads using INSIGHT software Adherence with Ventavis will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee as well as before and after participation in PAH patient support groups if applicable Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis adherence data Ventavis adherence data will also be collected one month after study entry
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