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Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

NCT02112487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-03-30

No results posted yet for this study

Summary

Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Conditions

Interventions

DRUG

Macitentan

10 mg once daily

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Loïc Perchenet · Actelion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-23
Primary Completion
2018-09-19
Completion
2018-09-19

Countries

  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112487 on ClinicalTrials.gov