Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05764265
Status:
TERMINATED
Last Update Posted:
2024-06-04
First Post:
2023-01-10
Brief Title:
Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Extension Study to Investigate Efficacy Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
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 study is to measure the long-term safety and efficacy profile of LTP001 in participants with pulmonary arterial hypertension PAH The study offers participants who had completed the CLTP001A12201 double-blind parent study in PAH an opportunity to receive LTP001 whether they were on LTP001 or not Unblinding of the treatment received in CLTP001A12201 is generally not needed but can occur on request by the investigator
Detailed Description:
This is a non-randomized open-label extension study of LTP001 for participants with PAH who complete the parent study CLTP001A12201 Eligible participants will be presented with the opportunity to enroll in the extension study at the end of treatment visit of the parent study Participants in the extension study will receive a once daily dose of LTP001 for 52 weeks regardless of their parent study treatment ie LTP001 or placebo Visits to assess the safety tolerability and efficacy of LTP001 will take place at Weeks 5 13 26 39 and 52 including a right heart catheterization at Week 26 and a 6-minute walk test and echocardiography at Weeks 26 and 52 Participants will have safety follow-up phone calls at week 9 and 17 and may be invited for unscheduled assessments at the site if deemed necessary At Week 56 approximately 30 days after the treatment period participants will have one safety follow-up phone call The safety and efficacy profile of LTP001 observed in this extension study as well as the parent study will determine the continuation of the extension study
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 |
|---|---|---|---|
| 2022-002007-38 | EUDRACT_NUMBER | None | None |