← Back to Search

Prostacyclin Receptor Agonist

Selexipag for Pulmonary Arterial Hypertension

Phase 2

Waitlist Available

Research Sponsored by Actelion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's enrollment

Word Health Organization functional class (WHO FC) II to III

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

Study Summary

This trial is to confirm that the selexipag starting dose(s) extrapolated from adults based on pharmacokinetics leads to similar exposure in children 2-18 years old with Pulmonary Arterial Hypertension.

Who is the study for?

This trial is for children aged 2-18 with Pulmonary Arterial Hypertension (PAH), weighing at least 9 kg. They must have a confirmed PAH diagnosis and be in WHO functional class II to III. Those on stable PAH-specific treatments can join, except if they've used selexipag recently or certain other PAH drugs within the last two months.Check my eligibility

What is being tested?

The study tests the drug selexipag (Uptravi) in children to find the right starting dose that matches adult exposure levels. It will look at how kids' bodies process the drug and its active metabolite, focusing on those between ages 2 and under 18 with PAH.See study design

What are the potential side effects?

Selexipag may cause side effects like headaches, diarrhea, jaw pain, muscle pain or cramps, nausea or vomiting, redness of skin or rash. The severity of these side effects can vary from child to child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PAH confirmed by a heart catheterization test.

Select...

My heart condition moderately affects my daily activities.

Select...

I am between 2 and 18 years old and weigh at least 9 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State of Selexipag and Its Metabolite ACT-333679 Combined (AUCτ, ss, Combined)

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve Over a Dose Interval of ACT-333679 at Steady State (AUCτ,ss)

Area Under the Plasma Concentration-time Curve Over a Dose Interval of Selexipag at Steady State (AUCτ,ss)

Change From Baseline Over Time in Body Mass Index (BMI) up to EOT + 3 Days

+19 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: open label selexipagExperimental Treatment1 Intervention

The first dose of selexipag (Uptravi) will be administered in the evening of Day 1 and will be based on the body weight. Thereafter selexipag will be administered twice daily (morning and evening). Selexipag will be up-titrated during the first 12 weeks, with weekly increments equal to the starting dose until the participants reach their individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline weight category is achieved (which will be 8-fold of the corresponding starting dose). Up-titration is followed by a stable maintenance treatment period from Week 12 to Week 16, at the maximum tolerated dose. Thereafter, participants will be treated with selexipag as long as the treatment is beneficial to the participants, as per investigator's decision.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor

191 Previous Clinical Trials

35,630 Total Patients Enrolled

66 Trials studying Pulmonary Arterial Hypertension

15,922 Patients Enrolled for Pulmonary Arterial Hypertension

Catherine BoissonStudy DirectorActelion

Media Library

Selexipag (Prostacyclin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03492177 — Phase 2

Pulmonary Arterial Hypertension Research Study Groups: open label selexipag

Pulmonary Arterial Hypertension Clinical Trial 2023: Selexipag Highlights & Side Effects. Trial Name: NCT03492177 — Phase 2

Selexipag (Prostacyclin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03492177 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people total are participating in this research project?

"Unfortunately, this clinical trial is no longer enrolling patients. It was initially posted on July 23rd, 2018 but the most recent update was on November 8th, 2022. If you are looking for similar studies, there are 789 trials for pulmonary arterial hypertension and 5 trials using selexipag (Uptravi) that might be of interest and are still recruiting patients."

Answered by AI

Does this research project allow for elderly participants?

"In order to meet the requirements for this clinical trial, applicants must be aged 2-17. Out of the 756 total clinical trials, 58 are designed specifically for individuals under 18 years old while 698 are meant for patients that are over 65."

Answered by AI

Are there any available spots left for this research project?

"According to the information found on clinicaltrials.gov, this particular trial is not currently looking for participants. The trial was originally posted on July 23rd, 2018 but has since been updated on November 8th, 2020. Although this study is not taking volunteers at the moment, there are 794 other trials that are."

Answered by AI

Do we have any evidence from other research projects involving selexipag (Uptravi)?

"UZ Gent was the first to study selexipag (Uptravi) in 2018, and there have been 16 completed clinical trials since then. As of now, 5 more clinical trials are underway with many taking place in Seattle, Washington."

Answered by AI

How do I know if I can join this particular research study?

"This trial is testing the effects of the study medication on 63 young patients with pulmonary arterial hypertension. The patient must be a male or female aged 2 to 17 years old, weigh at least 9 kg, have WHO FC II-III, and have idiopathic (iPAH) or drug/toxin-induced PAH."

Answered by AI

How often do people experience negative side effects from taking selexipag?

"While there is some evidence of selexipag's safety, it did not receive a high score because Phase 2 trials lack data proving the medication's efficacy."

Answered by AI

Is this research breaking new ground?

"Selexipag (Uptravi), which was first trialed in 2018, has been the subject of 5 active clinical trials since then. The 63-person study conducted in 2018 led to selexipag's Phase 2 drug approval. Currently, these trials are being held in 45 cities across 43 nations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

2018. "A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03492177.

All > Pulmonary Arterial Hypertension > Pulmonary Hypertension