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Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

NCT01739400 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2019-04-16

Study results available
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Summary

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Conditions

Interventions

DRUG

Macitentan 10 mg tablet, once daily.

Macitentan 10 mg tablet, once daily.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-10
Primary Completion
2018-01-12
Completion
2018-01-12
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Chile
  • China
  • France
  • Germany
  • Greece
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Spain
  • United Kingdom
  • Vietnam

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 NCT01739400 on ClinicalTrials.gov