Trial NCT03775421

View at ClinicalTrials.gov 
Org. Study IDs: AC-055H302
Secondary IDs: 2018-002821-45

Last trial update was posted on 2023-03-07

MeSH Interventions

Macitentan

MeSH Conditions

Heart Defects, Congenital Heart Diseases

Other Conditions

Congenital Heart Disease With Fontan Circulation

Stopping Reasons

As The RUBATO DB study (NCT03153137) did not show any benefit of treatment with macitentan in Fontan-palliated participants, the sponsor has decided to terminate the RUBATO OL study (NCT03775421). No new safety observations were made.

Limitations And Caveats

The study was stopped prematurely by the sponsor because the main double-blind (DB) study (AC-055H301; NCT03153137) did not meet the primary and secondary efficacy outcome measures.

Result Publications

N/A

Annotations

Category Annotations
No annotators decided on categories yet

Intervention Annotations
# Outdated Intervention Condition
Name Route DrugBank ID