Pulmonary arterial hypertension MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: LTP001
Product Code: LTP001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not available
Current Sponsor code: LTP001
Other descriptive name: LTP001
Concentration unit: mg milli
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To assess the safety and tolerability of LTP001 in participants with PAH - To investigate the pharmacokinetics (PK) of LTP001 ;Primary end point(s): Change from baseline PVR at week 25;Timepoint(s) of evaluation of this end point: At week 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in 6MWD at week 13 and week 25 - Right heart catheterization assessments including RV pressures, pulmonary artery pressures, wedge pressure, and cardiac output at week 25 - Change from baseline in tricuspid annular plane systolic excursion (TAPSE) by echocardiography at week 5, 13 and 25 - Change from baseline in tricuspid annular systolic velocity (TASV) by echocardiography at week 5, 13 and 25 - Change from baseline of peak velocity of excursion (RV S') by echocardiography at week 5, 13 and 25 - Change from baseline in fractional area change (FAC) by echocardiography at week 5, 13 and 25 - Change from baseline in EmPHasis-10 and PAH-SYMPACT at week 13 and 25 - AEs, SAEs, vital signs, ECGs, safety laboratory measurements - Time to Clinical Worsening - Cmax and Tmax (week 1 and Week 25) Change from baseline in N-terminal fragment of the prohormone B-type natriuetic peptide (NT-ProBNP) ;Timepoint(s) of evaluation of this end point: At weeks 13 and 25 At week 25 At week 5, 13 and 25 At week 5, 13 and 25 At week 5, 13 and 25 At week 5, 13 and 25 At week 13 and 25 Baseline to Week 29 Baseline to Week 29 week 1 and week 25 Baseline to week 29 | — |
Countries
Argentina, Germany, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed