Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02939599
Status:
TERMINATED
Last Update Posted:
2021-01-05
First Post:
2016-10-12
Brief Title:
Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Long-term Open Label Multicenter Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension PAH
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated early for strategic reasons Only Part I of the study was completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374 The study will monitor the long-term safety tolerability and efficacy of QCC374 in patients with PAH
Detailed Description:
None
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