An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertensio

Phase 2

Conditions: increases blood pressure in the pulmonary circulation
10037454

Registration Number: NL-OMON53913

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Participant is currently completing the Novartis-sponsored study
CLTP001A12201 in PAH and completed key efficacy and safety procedures up to the
end of treatment of the parent study, without
meeting discontinuation criteria in the parent study.
• Willingness and ability to comply with scheduled visits, treatment plans and
any other study procedures.
• Participant currently has no evidence of treatment failure, as determined by
the investigator, following previous treatment.
• In the opinion of the Investigator the participant would benefit from LTP001
treatment.

Exclusion Criteria

• History of hypersensitivity to the study treatment.
• Required or planned transplant or heart/lung surgery.
• Acute or chronic impairment (other than dyspnea), which would limit the
ability to comply with study requirements, including interference with physical
activity or execution of study procedures such as 6MWT (e.g., angina pectoris,
claudication, musculoskeletal disorder, need for
walking aids).
• Permanent discontinuation of Novartis drug in the parent study due to
toxicity or disease progression, non-compliance to study procedures, withdrawal
of consent or any other reason.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the long-term safety of LTP001 in participants with pulmonary<br /><br>arterial hypertension (PAH), based on AEs, SAEs, vital signs, ECGs, safety<br /><br>laboratory measurements.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the effect of LTP001 on hemodynamic parameters derived from RHC<br /><br>- To assess the effect of LTP001 on the 6MWD<br /><br>- To assess the effect of LTP001 on measurements of right ventricular function<br /><br>- To assess the impact of LTP001 on Time to Clinical Worsening.<br /><br>- To assess the impact of LTP001 on patient reported outcomes.<br /><br>- To assess the impact of LTP001 on the N-terminal fragment of the prohormone<br /><br>B-type natriuretic peptide</p><br>