Study of Efficacy and Safety of LTP001 in Pulmonary Arter... | NCT05135000

Label	Type	Description	Intervention Names
LTP001	Experimental	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks	Drug: LTP001
Placebo	Placebo Comparator	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LTP001	Drug	LTP001, 6 mg, was administered orally once daily in the morning	LTP001

Measure	Description	Time Frame
Change From Baseline in Right Heard Catheterization Pulmonary Vascular Resistance (PVR) at Week 25	PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5	Baseline, Week 25

Measure	Description	Time Frame
Change From Baseline in Six Minute Walk Distance (6MWD)	6MWD test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes	Baseline, Weeks 13 and 25
Change From Baseline in Right Atrium (RA) Pressures at Week 25

Eligibility Module

Eligibility 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 (mPAP) > 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg, as determined by right heart catheterization within 20 days of randomization.
Pulmonary Vascular Resistance > 6 Wood units (480 dynes s/cm-5), as determined by right heart catheterization within 20 days of randomization.
WHO Functional Class II-III
6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to be within 20 days of randomization. To meet the above criterion additional six minute walk test (6MWT) may be performed up to a maximum of 3 tests in total prior to dosing; the minimal time difference between two tests should be at least 4 h.
- Standard of care therapy which is stable at least 6 weeks prior to RHC and qualifying 6MWT assessment within 20 days of randomization. Standard of care includes one or more of the following treatments:
- prostacyclin analogues and receptor agonists (if I.V., dose adjustments must be within 20% of initial stable dose)
- endothelin receptor antagonists (ERAs)
- phosphodiesterase type 5 inhibitors (PDE5i)
- soluble guanylate cyclase (sGC) stimulators

Exclusion Criteria:

Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion Criterion #4.
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 (non-symptomatic, revascularized coronary artery disease would be acceptable).
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. Testing must have occurred within 24months of screening. If historical testing is not available, then lung function testing must be conducted during the screening period.
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 (e.g., angina pectoris, claudication, musculoskeletal disorder, multiple sclerosis, need for walking aids).

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Associates PA		Mesa	Arizona	85206	United States
Medical Univ of South Carolina

Label	URL
A Plain Language Trial Summary is available on www.novctrd.com	View source

ID	Title	Description
FG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
FG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 1, 2022	Mar 18, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Right Heard Catheterization Pulmonary Vascular Resistance (PVR) at Week 25

PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

dynes.sec.cm^-5

Baseline, Week 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG00024 OG0018

Title

Denominators

Categories

Title	Measurements
	OG000-1.175± 254.0792 OG001-49.685± 181.3745

Secondary

Change From Baseline in Six Minute Walk Distance (6MWD)

6MWD test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

meters

Baseline, Weeks 13 and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Right Atrium (RA) Pressures at Week 25

The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pulmonary Capillary Wedge Pressure at Week 25

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Pulmonary Artery Pressure at Week 25

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary artery pressure.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Average Cardiac Output (CO) at Week 25

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including cardiac output (CO).

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

liters per minute

Baseline, Week 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fractional Area Change (FAC)

Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

percent

Baseline, Weeks 5, 13, and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Peak Velocity of Excursion (RV S')

Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S') are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S' as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S') are identical. Therefore, the TASV and RV S' data in this results disclosure are the same.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

centimeters per second

Baseline, Weeks 5, 13, and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)

Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

centimeters

Baseline, Weeks 5, 13, and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)

Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

centimeters per second

Baseline, Weeks 5, 13 and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in EmPHasis-10

emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

score

Baseline, Weeks 13 and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)

PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

score

Baseline, Weeks 13 and 25

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Maximum Observed Blood Concentrations (Cmax) for LTP001

The maximum (peak) observed blood drug concentration after single dose administration.

The pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any study drug, and without protocol deviations that impacted PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 1 and Week 25 at 15, 45, and 120 minutes post-dose

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Time to Reach Maximum Blood Concentrations (Tmax) of LTP001

The time to reach maximum (peak) blood drug concentration after single dose administration.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Day 1 and Week 25 at 15, 45, and 120 minutes post-dose

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Secondary

Time to Clinical Worsening

Time to any of the following:

Death
Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension
Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy
Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension
Significant drop in six minute walk distance

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data. Participants without the event were considered as censored at the end of the time at risk.

Posted

Median

95% Confidence Interval

days

Baseline up to approximately 30 weeks

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts

Secondary

Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)

NT-proBNP is a blood biomarker to assess right ventricular distress.

The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

picomoles per liter

Baseline to Week 29

ID	Title	Description
OG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
OG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Palpitations	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected35 at risk EG0011 affected12 at risk EG0024 affected47 at risk
Tachycardia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Nausea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected35 at risk EG0011 affected12 at risk EG0025 affected47 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0011 affected12 at risk EG0022 affected47 at risk
Asthenia	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Chest discomfort	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Fatigue	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0011 affected12 at risk EG0023 affected47 at risk
Influenza like illness	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0011 affected12 at risk EG0022 affected47 at risk
Peripheral swelling	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Bronchitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Influenza	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0003 affected35 at risk EG0010 affected12 at risk EG0023 affected47 at risk
Nasopharyngitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Respiratory tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0003 affected35 at risk EG0010 affected12 at risk EG0023 affected47 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Headache	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0006 affected35 at risk EG0010 affected12 at risk EG0026 affected47 at risk
Presyncope	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0011 affected12 at risk EG0023 affected47 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0011 affected12 at risk EG0023 affected47 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0011 affected12 at risk EG0022 affected47 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Haematoma	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected12 at risk EG0022 affected47 at risk

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks
BG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LTP001	Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks	35	5	35	20	35
EG001	Placebo	Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks	12	2	12	7	12
EG002	Total	Total	47	7	47	27	47

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Right ventricular failure	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected12 at risk EG0021 affected47 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected35 at risk EG0010 affected12 at risk EG0021 affected47 at risk

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary