oUtcome study assessing a 75 mg dose of macitentaN In patientS with pUlmonary arterialhypertenSio

Phase 3

• Conditions: Health Condition 1: I270- Primary pulmonary hypertension

• Registration Number: CTRI/2023/02/049676
• Lead Sponsor: Janssen Research & Development , LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 At least 18 years of age

2 Symptomatic PAH in WHO FC II, III, or IV

3 PAH subtype falling in one of the below classifications:

4 Idiopathic, heritable, drug- or toxin-induced, or

related to connective tissue disease, HIV infection,

portal hypertension, or congenital heart disease

5 Have a PAH diagnosis confirmed by hemodynamic

evaluation at rest at any time prior to screening:

- Mean pulmonary artery pressure (mPAP) >

20 mm Hg, AND

- Pulmonary artery wedge pressure (PAWP) or

left ventricular end diastolic pressure (LVEDP)

= 15 mm Hg, AND

- Pulmonary vascular resistance (PVR) = 3 Wood Units (i.e., = 240 dyn•sec•cm-5)

Additional criteria will be assessed at the screening visit.

Exclusion Criteria

1 Known presence of three or more of the following risk

factors for heart failure with preserved ejection fraction

at screening, based on records that confirm documented

medical history:

- Body mass index (BMI) > 30 kg/m2

- Diabetes mellitus of any type

- Essential hypertension (even if well controlled)

- Coronary artery disease, i.e., any of the following:

– History of stable angina, known more than

50% stenosis in a coronary artery, history of

myocardial infarction, or history of or planned

coronary artery bypass grafting and/or coronary

artery stenting

2 Presence of moderate or severe obstructive or restrictive

lung disease in patients with a known or suspected

history of significant lung disease

Additional criteria will be assessed at the screening visit.

3 Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin,

rifapentin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) within 1 month

prior to randomization or start of run-in, if applicable

4 Treatment with a strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole,

voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) or a

moderate dual CYP3A4/CYP2C9 inhibitor (eg, fluconazole, amiodarone) or coadministration

of a combination of moderate CYP3A4 (eg, ciprofloxacin, cyclosporine,

diltiazem, erythromycin, verapamil) and moderate CYP2C9 inhibitors (eg, miconazole,

piperine), in the 1-month period prior to randomization, or start of run-in, if applicable.

External use (cream, shampoo, etc) per approved label is permitted.

5 Significant unrepaired structural left heart valvular disease (ie, moderate or severe

aortic or mitral stenosis or regurgitation); pericardial constriction; restrictive or

congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant

left ventricular dysfunction; or left ventricular outflow obstruction

6 Known or suspected pulmonary veno-occlusive disease (PVOD)

7 Permanent atrial fibrillation or atrial flutter, in the opinion of the investigator.

8 Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history.

Study & Design

• Study Type: Interventional
• Study Design: Not specified