Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03078907
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2017-03-06
Brief Title:
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multi-center Double-blind Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patients Self-reported Symptoms and Their Impacts
Status:
COMPLETED
Status Verified Date:
2021-02
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:
TRACE
Brief Summary:
The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension PAH in their daily life by using a wearable wrist device actigraph The actigraph will collect data on daily life physical activity in the patients real environment In addition the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patients real environment Patients will be assigned randomly to either selexipag or placebo
Detailed Description:
This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None