Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01824290
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2013-04-01
Brief Title:
A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension PAH
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-11
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 main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension Participants will receive study treatment for 6 months in the double-blind period Period 1 and then will be eligible to enroll into an open-label 2 year extension period Period 2 during which participants will receive tadalafil
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H6D-MC-LVHV | OTHER | None | None |
| 2012-002354-23 | EUDRACT_NUMBER | Eli Lilly and Company | None |