Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05135000
Status:
TERMINATED
Last Update Posted:
2024-06-04
First Post:
2021-11-16
Brief Title:
Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Participant- and Investigator-blinded Placebo-controlled 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 explore the efficacy and safety of LTP001 in participants with pulmonary arterial hypertension PAH to determine if LTP001 has an adequate clinical profile to warrant further clinical development in this indication
Detailed Description:
This is a non-confirmatory randomized subject- and investigator-blinded placebo controlled study of LTP001 in PAH participants Approximately 44 male and female adults with PAH participants will be randomized in a 31 ratio of LTP001 active dose to placebo Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing with visits approximately every 4 weeks One follow up visit will also be the end of study visit and occurs approximately 30 days after the end of treatment Total study duration is approximately 37 weeks from start of screening to end of study visit If a participant continues into the open-label extension study then the follow-up visit may be skipped
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