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Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants

Pulmonary Arterial Hypertension Clinical Trial

Official title:
An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension

Clinical Trial 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.

Clinical Trial 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 (i.e. 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. 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05764265
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date March 27, 2023
Completion date May 14, 2024
View Details
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