Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

CompletadoFase 3ClinicalTrials.gov

ID: NCT00667823Tipo: INTERVENTIONALInicio: 17 de oct de 2008Fin estimado: 7 de dic de 2020

Traducción no disponible, mostrando original

Resumen

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Signed informed consent prior to initiation of any study-mandated procedure.
Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Criterios de exclusión

Any major violation of protocol AC 055 302/SERAPHIN.
Pregnancy or breast-feeding.
AST and/or ALT \> 3 times the upper limit of the normal range.
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
Known hypersensitivity to ACT 064992 or any of the excipients.

Intervenciones

drug

Macitentan

Tablet, oral administration, 10 mg dose once daily

Ubicaciones

Sanatorio Otamendi y Miroli S.A.

Buenos Aires, Ciudad Autonoma, Argentina

Hospital Britanico

Buenos Aires, Ciudad Autonoma, Argentina

Sanatorio MITRE

Buenos Aires, Argentina

Fundacion Favaloro

Buenos Aires, Argentina

Instituto Cardiologia Corrientes

Corrientes, Argentina

Htal Italiano Cordoba

Córdoba, Argentina

Htla privado de Cordoba

Córdoba, Argentina

Hospital Italiano - Garibaldi de Rosario

Santa Fe, Argentina

Patrocinadores

PrincipalActelion

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