Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02927366
Status:
TERMINATED
Last Update Posted:
2021-01-05
First Post:
2016-10-05
Brief Title:
Safety Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Parallel-group Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety Tolerability Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial Hypertension
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 was a non-confirmatory randomized placebo controlled subject and investigator blinded study of QCC374 in PAH subjects The study was planned to have 2 Parts Part 1 an initial safety cohort with a 003 mg bid starting dose and Part 2 a larger cohort with a 006 mg bid starting dose However due to early study termination following Part 1 Part 2 was not completed Both study parts were comprised of four phases a screening period for up to 28 days a titration period of 2 weeks a stable dose period of 14 weeks and safety follow-up period for 28 days At the end of the treatment period of 16 weeks eligible patients were given the option to participate in a separate long-term extension study CQCC374X2201E1 NCT02939599 where all patients were treated with an individual optimal dose of QCC374
Detailed Description:
The decision for early termination was based on changes in Novartis strategy and was not based on any safety concerns regarding QCC374 Only Part 1 of the study was completed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001412-38 | EUDRACT_NUMBER | None | None |