Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

• Status: Completed
• Trial end date: 2021-07-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Macitentan

Criteria

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