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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

Must not have

Known concomitant life-threatening disease with a life expectancy less than 12 months

Previous exposure to Uptravi (selexipag)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious illness and am expected to live less than a year.

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I have been treated with Uptravi before.

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My PAH is caused by portal hypertension, schistosomiasis, or specific lung diseases.

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My PAH is linked to Eisenmenger syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Disease Progression

Secondary study objectives

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

Nasopharyngitis

Nasal Congestion

Flushing

Fatigue

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

Placebo

Selexipag

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met