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

Description

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

Study Start Date

November, 30 2017

Estimated Completion Date

March 2020

Interventions

  • Drug: Placebo
  • Drug: Macitentan 10 mg

Study ID

Actelion -- AC-055H301

Status

Recruiting

Trial ID

NCT03153137

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

134

Sponsor

Actelion

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

Gender

All

Ages

12 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital Heart Center - Boston, Massachusetts 2.8 miles Principal Investigator 617-726-8510 ddo2@partners.org

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