Ignite Creation Date:
2024-05-05 @ 10:43 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01179737
Status:
TERMINATED
Last Update Posted:
2014-05-01
First Post:
2010-08-03
Brief Title:
Efficacy Safety Tolerability and Pharmacokinetics PK of Nilotinib AMN107 in Pulmonary Arterial Hypertension PAH
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 24 Week Randomized Double Blind Multicenter Placebocontrolled Efficacy Safety Tolerability and PK Trial of Nilotinib Tasigna AMN107 in Pulmonary Arterial Hypertension PAH
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to serious adverse event SAE
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 trial was to establish the safety tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months treatment with nilotinib will significantly reduce pulmonary artery resistance
Detailed Description:
The purpose of this trial was to establish the safety tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months
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 |
|---|---|---|---|
| 2010-019883-36 | EUDRACT_NUMBER | None | None |