Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease

Phase 3

Withdrawn

Conditions: hypertension in the pulmonary arteries
Pulmonary arterial hypertension due to congenital heart disease
10010394

Registration Number: NL-OMON43116

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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

Exclusion Criteria

- WHO functional class I of 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage change in exercise capacity (either V*O2peak in cardiopulmonary<br /><br>exercise test or 6-minute walk distance) between baseline and 6 months of<br /><br>treatment with selexipag</p><br>

Secondary Outcome Measures