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Clinical Trial 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.


Clinical Trial 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 3:1 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 Design


Related Conditions & MeSH terms


NCT number NCT05135000
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date June 30, 2022
Completion date April 25, 2024

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