Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants

Phase 1

• Conditions: Pulmonary arterial hypertension; MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-000670-28-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-04
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

- History of PAH belonging to one of the following subgroups of the Clinical Classification Group 1 (WHO):
--> participants with idiopathic pulmonary arterial hypertension (IPAH)
--> Hereditary pulmonary arterial hypertension
--> Congenital heart disease (surgically repaired at least 12 months prior to screening)
--> drug or toxin induced (for example, anorexigen or methamphetamine use)
- Resting mean pulmonary arterial pressure > 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg as determined by right heart catheterization
- Pulmonary Vascular Resistance > 6 Wood unites (480 dynes s/cm5), as determined by right heart catheterization
- WHO Functional Class II-III
- 6MWD must be between 150 and 550 m (inclusive).
- Standard of care therapy which is stable at least 6 weeks prior to RHC and 6MWT assessment

Other protocol-defined criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

- Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups that were not covered by the inclusion criteria.
- Participants with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease compromising left ventricular function and/or pulmonary venous hypertension or symptomatic coronary disease
- Participants with obstructive lung disease defined as: FEV1/FVC < 60% and FEV1 < 60% of predicted value after bronchodilator administration as well as participants with moderate or severe restrictive lung disease: Total Lung Capacity < 70% of predicted value.
- Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity and execution of study procedures such as 6MWT .

Other protocol-defined criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of LTP001 in participants with pulmonary arterial hypertension;Secondary Objective: - To evaluate the effect of LTP001 on other efficacy measures, Patient reported outcomes and biomarkers<br>- To assess the safety and tolerability of LTP001 in participants with PAH<br>- To investigate the pharmacokinetics (PK) of LTP001<br><br>;Primary end point(s): Change from baseline PVR at week 25;Timepoint(s) of evaluation of this end point: At week 25