Purpose

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures - Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection - New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale - Women of childbearing potential must have a negative serum pregnancy test use reliable contraception

Exclusion Criteria

  • Pattern of Fontan circulation severity - Deterioration of the Fontan-palliated condition. - Limitations to Cardiopulmonary exercise testing (CPET) - Peak VO2 < 15 mL/kg/min. - Any known factor or disease that may interfere with treatment compliance or full participation in the study

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Macitentan
Macitentan 10 mg per day; film-coated tablet; oral use
  • Drug: Macitentan 10 mg
    film-coated tablet; oral use
Placebo Comparator
Placebo
film-coated tablet; oral use
  • Drug: Placebo
    film-coated tablet; oral use

More Details

Status
Completed
Sponsor
Actelion

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.