Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect

Phase 1

• Conditions: Pulmonary arterial hypertension related to congenital heart disease.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003495-53-NL
• Lead Sponsor: Academic Medical Center - Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male and female patients = 18 years old
-Symptomatic PAH related to congenital heart disease of all complexities
-WHO functional class II-III
-Documented hemodynamic diagnosis of PAH by right heart catheterization or echocardiography, performed at time prior to screening
-Patients not receiving treatment for PAH or those who are receiving endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor or both at a dose that has been stable for 3 months
-Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-WHO functional class IV
-Patients who have received prostacyclin (analogs) treatment within 1 month before baseline visit or are scheduled to receive any of these drugs during the trial
-Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
-Females who are lactating or pregnant or plan to become pregnant during the study (a pregnancy test is offered to every female patient within the fertile age)
-Known hypersensitivity to any of the excipients of the drug formulations
-Contraindication for trial medication
-Contraindication for cardiopulmonary exercise test
-Incapable of giving informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified