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Selexipag for Pulmonary Arterial Hypertension (SALTO Trial)

Phase 3

Waitlist Available

Research Sponsored by Actelion

Eligibility Criteria Checklist

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

Must have

Participants between 2 and 18 years of age weighing at least 9 kilograms at randomization

WHO functional class (FC) II and III

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 16, 24 and every 12 weeks thereafter (up to 8 years)

Awards & highlights

SALTO Trial Summary

This trial is testing if a new drug can help kids with Pulmonary Arterial Hypertension by delaying disease progression.

Who is the study for?

This trial is for children aged 2-18 with Pulmonary Arterial Hypertension (PAH) who are already on stable PAH treatment. They must weigh at least 9 kg and have a confirmed diagnosis through right heart catheterization. It's not for those with certain types of PAH, previous selexipag use, life-threatening diseases, or pregnancy.Check my eligibility

What is being tested?

The study tests if adding Selexipag to standard treatments can slow down the progression of PAH in children compared to a placebo. Participants will be randomly assigned to receive either Selexipag or a placebo alongside their current treatment.See study design

What are the potential side effects?

Selexipag may cause side effects like headaches, diarrhea, jaw pain, nausea, muscle pain or cramps, vomiting and flushing. The severity of these side effects can vary from person to person.

SALTO Trial Eligibility Criteria

Inclusion Criteria

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

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

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My heart condition allows me to perform light to moderate activities.

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My PAH diagnosis was confirmed by a heart catheterization test.

SALTO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 16, 24 and every 12 weeks thereafter (up to 8 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 16, 24 and every 12 weeks thereafter (up to 8 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 16, 24 and every 12 weeks thereafter (up to 8 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

Time to Disease Progression

Secondary outcome measures

Change from Baseline at Week 24 in Log2 N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

Change from Baseline in Body Weight

Change from Baseline in Height

+10 more

Side effects data

From 2020 Phase 4 trial • 108 Patients • NCT03078907

77%

Headache

53%

Diarrhoea

42%

Nausea

38%

Pain in Jaw

25%

Vomiting

21%

Arthralgia

21%

Pain in Extremity

13%

Dizziness

11%

Dyspepsia

11%

Upper Respiratory Tract Infection

11%

Myalgia

Flushing

Nasopharyngitis

Fatigue

Nasal Congestion

Dyspnoea

Decreased Appetite

Back Pain

Oedema Peripheral

Cough

Epistaxis

Palpitations

Non-Cardiac Chest Pain

Lower Respiratory Tract Infection

Abdominal Pain Upper

Oropharyngeal Pain

Rash

Respiratory Tract Infection

Atrial Flutter

Right Ventricular Failure

Migraine

Abdominal Distension

100%

80%

60%

40%

20%

Study treatment Arm

Selexipag

Placebo

SALTO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SelexipagExperimental Treatment1 Intervention

Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selexipag

2016

Completed Phase 4

~1750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor

191 Previous Clinical Trials

35,555 Total Patients Enrolled

Actelion Clinical TrialStudy DirectorActelion

13 Previous Clinical Trials

893 Total Patients Enrolled

Media Library

Selexipag Clinical Trial Eligibility Overview. Trial Name: NCT04175600 — Phase 3

Pulmonary Hypertension Research Study Groups: Selexipag, Placebo

Pulmonary Hypertension Clinical Trial 2023: Selexipag Highlights & Side Effects. Trial Name: NCT04175600 — Phase 3

Selexipag 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175600 — Phase 3

Frequently Asked Questions

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

Would this experimental therapy be appropriate for patients above the age of 50?

"This particular clinical trial is for patients aged 2 to 17. Out of the 61 clinical trials conducted for people under 18, this is one of them. On the other hand, there are 710 clinical trials for people over 65."

Answered by AI

What sets this experiment apart from others like it?

"Selexipag has had a relatively short journey in clinical research, with the first study being published in 2018. Actelion was the primary sponsor for this 63-person Phase 1 trial. Due to the success of this initial testing Selexipag received approval for Phase 2 trials. Currently, 5 separate studies are ongoing and recruiting patients from 45 different cities across 43 countries."

Answered by AI

In how many different medical clinics is this research project being carried out today?

"In addition to other medical facilities, this trial is taking place at Children's National Medical Center in Washington D.C., Texas Children's Hospital in Houston, Texas, and Congenital Heart Center of the University of Florida in Gainesville, Florida."

Answered by AI

Are patients being accepted for enrollment in this trial at this time?

"That is accurate. The information available on clinicaltrials.gov reveals that this study, which was first publicized on 16th January 2020, is presently looking for participants. There are 237 spots open at 16 different hospitals or clinics."

Answered by AI

How can I sign up for the research project?

"This clinical trial is looking for 237 participants, between the ages of 2 and 17 who currently have hypertension, pulmonary. It is required that participants also meet the following criteria: Participants between greater than or equal to (>=) 2 and less than (<) 18 years of age weighing >=9 kilogram (kg) at randomization, Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's screening, PAH (World Health Organization [WHO] Group 1), including participants with Down syndrome, of the following etiologies: Idiopathic PA"

Answered by AI

What other research has been done on Selexipag in the past?

"Originally, selexipag was researched in 2018 at UZ Gent. Out of the 18302 completed clinical trials, 5 are ongoing as of today. Most of these live studies are situated in Washington D.C."

Answered by AI

Are there any harmful side effects associated with Selexipag?

"Selexipag has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, which suggests that not only does some data support efficacy, but multiple rounds also support safety."

Answered by AI

How many people have been chosen to participate in this experiment?

"In order to carry out this research, the study sponsor, Actelion, needs 237 patients that fulfill the inclusion criteria. The trial will take place in various locations including Children's National Medical Center (Washington D.C.) and Texas Children's Hospital (Houston)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

2020. "A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175600.

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