NL-OMON54353
Recruiting
Phase 3
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pulmonary Hypertension
- Sponsor
- Janssen-Cilag
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Target population: greater than or equal to (\>\<\=) 18 (or the legal age of
- •consent in the jurisdiction in which the study is taking place) years of age
- •\- Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World
- •Health Organization,Functional Class (WHO FC) II, III, or IV
- •\- Target population: PAH subtype falling in one of the below classifications:
- •Idiopathic; Heritable; Drug\- or toxininduced; Related to: Connective tissue
- •disease, HIV infection, Portal hypertension, and Congenital heart disease with
- •small/coincidental cardiac defect with systemic\-to\-pulmonary shunt (for example
- •atrial septal defect, ventricular septal defect, patent ductus arteriosus,
- •atrioventricular septal defect) which does not account for the elevated
Exclusion Criteria
- •\- 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 kilograms per
- •meter square (kg/m^2\), Diabetes mellitus of any type, Essential hypertension
- •(even if well controlled); Coronary artery disease, that is, any of the
- •following: history of stable angina, or known more than 50 percent (%) stenosis
- •in a coronary artery, or history of myocardial infarction, or history of or
- •planned coronary artery bypass grafting and/or coronary artery stenting
- •\- Presence of moderate or severe obstructive lung disease (forced expiratory
- •volume in 1 second \[FEV1] / forced vital capacity \[FVC] \< 70%; and FEV1 \< 60%
Outcomes
Primary Outcomes
Not specified
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